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Senior Manager jobs in United States, Arizona, Tempe

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Company
Job type
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Job title (1)
United States
Arizona
Tempe
101 jobs found
22.11.2025
WP

West Pharma Senior Quality Engineer United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project...
Description:
Job Summary
In this role, you will provide quality direction, governance, and Quality Management System best practices across the programs you support. This role oversees multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment.
Essential Duties and Responsibilities
  • Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
  • Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
  • Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
  • Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.)
  • Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
  • Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
  • Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
  • May work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any other necessary quality records. Provide quality reports and review trending on assigned areas of responsibility.
  • May support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
  • May assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process Statistical Process Control programs.
  • May perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols, and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
  • May have people management responsibilities.
  • Other duties as assigned.
Education
  • Bachelor's Degree in Engineering or Science or equivalent experience required
Work Experience
  • Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required and
  • Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required and
  • In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required and
  • Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required and
Preferred Knowledge, Skills and Abilities
  • Experience with MasterControl, SAP, Share Point, Teamcenter
  • Experience with ISO 11040, ISO 11607
  • Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
  • Strong working knowledge of quality systems of the respective ISO norms
  • Working knowledge of supplier quality management from product development to mass production.
  • Strong project management skills
  • Proficient in computer system applications (SAP, master controls, etc) communication skills
  • Excellent critical reading and writing skills
  • Problem solving including root cause failure analysis methods
  • Be aware of all relevant SOPs as per Company policy as they relate to this role
  • Able to comply with the company’s safety and quality policies at all times
Additional Requirements
  • Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
  • Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
  • Ability to work independently, multi-task and thrive in fast-paced environment.
  • Strong problem-solving skills including root cause failure analysis methods.
  • Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
  • Must maintain the ability to work well with others in a variety of situations.
  • Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Ability to make independent and sound judgments.
  • Observe and interpret situations, analyze and solve problems.
License and Certifications
  • Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
  • Quality\Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
  • SO 17025 Auditor or Lead Auditor Training / Certification Upon Hire preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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22.11.2025
WP

West Pharma Manager Supply Chain United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
Mentor and may lead engineering team to achieve site and department goals in a fast-paced environment. Collaborate with cross-functional teams to develop and implement sustainable manufacturing processes and systems. Technical...
Description:
Job Summary
In this role, you will effectively plan and guide Engineering team, ensuring quality product and operational efficiencies are met.
Essential Duties and Responsibilities
  • Mentor and may lead engineering team to achieve site and department goals in a fast-paced environment.
  • Collaborate with cross-functional teams to develop and implement sustainable manufacturing processes and systems.
  • Technical and hands-on automated equipment troubleshooting, repair, and improvements.
  • Perform and document engineering studies and evaluations.
  • Analyze data to drive improvements, determine prioritization, and identify opportunities.
  • Lead and provide mentorship in root cause and corrective action (RCCA).
  • Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
  • Champion high-visibility projects. Develop project scope, timeline, savings, and cost estimations.
  • Quote new automation lines, engineering services, etc. Develop design concepts for new automation.
  • Write validation, user requirements, equipment specification, and other documents as needed.
  • Establishes relationships with customer and automation suppliers in pursuit of win?win results and ongoing business.
  • Provide engineering assistance to assure plant, machinery, and processes are at an optimum level.
  • Routinely evaluate and review employee performance.
  • Promote and support a Lean Manufacturing environment within the facility.
  • Research new technologies and methodologies to use in the plant.
  • Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Perform other duties as assigned based on business needs.
  • Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibit regular, reliable, punctual and predictable attendance.
  • Other duties as assigned.
Education
  • Bachelor's Degree In Engineering or Science field required
  • Master's Degree In Engineering or Science field preferred
Work Experience
  • Minimum 5 years 5-8 years of experience required and
  • 2+ years of managerial or supervisory experience in manufacturing environment required and
  • Strong automation background and experience with CAD and SAP systems a plus. preferred
Preferred Knowledge, Skills and Abilities
  • Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
  • Must have effective problem solving and interpersonal skills.
License and Certifications
  • Manufacturing\Six Sigma Green Belt Certification Six Sigma green belt Upon Hire preferred or
  • Manufacturing\Lean Six Sigma Black Belt Six Sigma black belt Upon Hire preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
  • Must be able to perform job duties as required with limited physical demands.
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08.11.2025
A

Amazon DCO Manager II United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
You will be a proven manager with experience managing teams of high performers. You will have the ability to refine and develop processes to optimize operational excellence in every area...
Description:
Description

You will be a proven manager with experience managing teams of high performers. You will have the ability to refine and develop processes to optimize operational excellence in every area of your role. You will be able to drive performance levels to achieve the pace we build and operate our Data Centers at. You will have previous experience in Data Centers, either building or managing (or both) along with exposure to developing great relationships with both internal teams and external vendors.Key job responsibilities
Maintaining existing Data CentersHelping build and bring online new Data CentersAssisting & managing relationships with external vendors & contractorsEnsuring we adhere to and exceed local Health & Safety standards in all our Data CentersCreating and maintaining metrics on all aspects of our Data Centers and utilizing those metrics to drive positive changesAssisting in implementing service methodologies including incident management, problem management, change management, capacity management, etc.A day in the life
A day in the life
You’ll join a diverse team of software, hardware, and network engineers, supply chain specialists, security experts, operations managers, and other vital roles. You’ll collaborate with people across AWS to help us deliver the highest standards for safety and security while providing seemingly infinite capacity at the lowest possible cost for our customers. And you’ll experience an inclusive culture that welcomes bold ideas and empowers you to own them to completion.
Amazon values diverse experiences. Even if you do not meet all of the preferred qualifications and skills listed in the job description, we encourage candidates to apply. If your career is just starting, hasn’t followed a traditional path, or includes alternative experiences, don’t let it stop you from applying.We’re continuously raising our performance bar as we strive to become Earth’s Best Employer. That’s why you’ll find endless knowledge-sharing, mentorship and other career-advancing resources here to help you develop into a better-rounded professional.

Basic Qualifications

- Experience managing a technical team
- A Bachelor's degree or 4+ years of professional or military experience in an IT related field.
- 2+ years of experience with Networking, or Computer hardware.


Preferred Qualifications

- 2+ years of previous Data Center Management experience.
- Effective communication and decision making skills
- Behavioral interviewing and hiring experience
- Formal project management certifications (Prince2, PMP, AGILE)
- Experience or Knowledge of AWS products: EC2, EBS, S3 and infrastructure and system redundancy (Power feeds, ATS, Server Hardware, RAID, Network Connectivity)

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18.09.2025
JPM

JPMorgan Senior Threat Associate - Global Security United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
Actively respond, manage and maintain cases of all case-types to include report writing and record retention. Conduct witness interviews and provide assessments as required. Provide program support for other GS/TM...
Description:

As a Senior Threat Associate within Global Security, you will provide continued support to employees through partnership with other key cross-functional partners as required. You will utilize your strong technical skills to help enhance the global team's risk and controls initiatives. You will be aligned to a particular function within the Threat Management organization but will be available to support other functions based on business needs. Your primary role will be to provide support functions for escalated threat cases throughout their entire lifecycle, including information gathering, initial threat assessment, consultation of stakeholders, incorporation of mitigation strategies, continued monitoring, and regular reviews of persons of concern.

Job responsibilities

  • Actively respond, manage and maintain cases of all case-types to include report writing and record retention
  • Conduct witness interviews and provide assessments as required
  • Provide program support for other GS/TM partners (Global Intelligence, Insider Risk)
  • Serve as liaison support for cross-functional partners
  • Provide case support for peer TMs as needed and based on caseload/on-call support
  • Support the development of best practice documents and standard response protocols
  • Utilize internal databases to execute long-term monitoring of persons of concern
  • Leverage partnerships to continuously monitor persons of concern
  • Support data integrity, TM case metrics, and trends analysis
  • Leverage technical skills (Microsoft office suite, ServiceNow, ArcGIS, Sales Force, Pega, Tableau, Power Bi, etc.) to enhance teams operational excellence

Required qualifications, capabilities, and skills

  • 3+ years’ experience in a threat management, law enforcement, intelligence analysis, and/or corporate security role
  • BA or BS Degree in History, Criminal Justice, Intelligence, or Political Science or equivalent years of relevant experience
  • Proficiency in MS office suite
  • Ability to think quickly and make decisions while under pressure
  • Ability to work within a team environment and achieve buy-in from stakeholders
  • Strong communication skills
  • Strong organization skills
  • Available to travel 10%
  • Able to work extended hours to include nights, weekends, and on-call as needed
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18.09.2025
JPM

JPMorgan Business Relationship Manager Senior - Acquisition United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
Acquire, retain and deepen a portfolio of approximately 40 business clients and 60 prospects in a growth/expansion stage with annual revenue greater than ~$3 million; provide business deposit and cash...
Description:

As a Business Relationship Manager Senior (BRM) Acquisition banker in Business Banking, you’ll be developing and managing a portfolio of large profitable business clients with annual revenue greater than ~$3MM. You’ll focus on business development, acquiring balances, deepening product utilization, and gaining referrals to increase primary bank share. As a Senior Acquisition banker, you will provide a high-touch experience by building relationships and providing financial advice with a focus on client experience and risk management, while focusing on acquiring new relationships, retaining and deepening existing relationships.

Job Responsibilities

  • Acquire, retain and deepen a portfolio of approximately 40 business clients and 60 prospects in a growth/expansion stage with annual revenue greater than ~$3 million; provide business deposit and cash management solutions and manage business credit opportunities up to $15 million; provide support to branch-based business bankers on sizeable business credit deals as needed
  • Deliver an outstanding experience to Chase business clients by providing comprehensive and customized business banking solutions tailored to the financial needs and circumstances of their businesses
  • Grow portfolio by prospecting for new clients whose businesses are in expansion mode; utilize extensive referral networks and centers of influence to independently identify and pursue potential new business clients, looking for ways to cultivate long-term primary banking relationships.
  • Develop strong referral network internally in partnership with Private Bank, Asset Wealth Management, Middle Market and One Chase to identify new opportunities for all partners
  • Leverage knowledge of diverse types of businesses, industries, markets, financial and economic concepts, as well as creative marketing techniques utilizing Chase resources and materials to develop business network and prospects
  • Develop relationships with clients, prospect and centers of influence through in-person/virtual calls to understand the needs of the business and its owners and develop the full financial relationship
  • Understand the personal financial goals and needs of the owner(s). Utilize knowledge of personal banking products and partner with Branch, Wealth Management and Private Bank to identify and deliver appropriate personal financial solutions
  • Partner with product specialists to ensure clients are onboarded seamlessly with end-to-end delivery of new accounts and full suite of products and services. Leverage service team to deliver an outstanding client experience
  • Protect the firm by following sound risk management protocols and control policies and adhering to regulatory requirements

Required qualifications, capabilities, and skills

  • Minimum of 5 years’ experience in a Business Banking Relationship Management role or related business lending experience
  • Strong current business network; active involvement in community organizations such as Chambers of Commerce, non-profit boards
  • Demonstrates strong tactical business development and negotiation skills. Self-directed, proactive, and creative; uses sound judgment and navigates ambiguity to get things done
  • Strong relationship-building and excellent communication skills with individuals at all levels, internally and externally. Ability to influence others to achieve desired outcomes and leverage technology to interact with clients effectively and efficiently
  • Strong knowledge of deposit and cash management products and services, and knowledge of business credit underwriting with commercial credit training. Uses seasoned judgment to offer comprehensive and customized solutions that best meet client needs; monitors and researches market/industry trends and business outcomes to anticipate client needs; presents proactive solutions and innovative alternatives when appropriate
  • Balance needs of clients with associated risks and interests of the firm
  • Excellent organizational skills and the ability to manage, prioritize, work under pressure and meet tight deadlines

Preferred qualifications, capabilities, and skills

  • Bachelor’s degree in Finance or related field, or equivalent work experience
  • Minimum of 3 years’ managing clients >$10+MM revenue
  • In-depth knowledge of diverse types of businesses, industries, markets, financial and economic concepts
  • Proficient in Microsoft Office tools including Outlook, Excel, Word, and PowerPoint
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These jobs might be a good fit

18.09.2025
JPM

JPMorgan Business Relationship Manager Senior - Acquisition- Vice Pre... United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
Acquire, retain and deepen a portfolio of approximately 40 business clients and 60 prospects in a growth/expansion stage with annual revenue greater than ~$3 million; provide business deposit and cash...
Description:

As a Business Relationship Manager Senior (BRM) Acquisition banker in Business Banking, you’ll be developing and managing a portfolio of large profitable business clients with annual revenue greater than ~$3MM. You’ll focus on business development, acquiring balances, deepening product utilization, and gaining referrals to increase primary bank share. As a Senior Acquisition banker, you will provide a high-touch experience by building relationships and providing financial advice with a focus on client experience and risk management, while focusing on acquiring new relationships, retaining and deepening existing relationships.

Job Responsibilities

  • Acquire, retain and deepen a portfolio of approximately 40 business clients and 60 prospects in a growth/expansion stage with annual revenue greater than ~$3 million; provide business deposit and cash management solutions and manage business credit opportunities up to $15 million; provide support to branch-based business bankers on sizeable business credit deals as needed
  • Deliver an outstanding experience to Chase business clients by providing comprehensive and customized business banking solutions tailored to the financial needs and circumstances of their businesses
  • Grow portfolio by prospecting for new clients whose businesses are in expansion mode; utilize extensive referral networks and centers of influence to independently identify and pursue potential new business clients, looking for ways to cultivate long-term primary banking relationships.
  • Develop strong referral network internally in partnership with Private Bank, Asset Wealth Management, Middle Market and One Chase to identify new opportunities for all partners
  • Leverage knowledge of diverse types of businesses, industries, markets, financial and economic concepts, as well as creative marketing techniques utilizing Chase resources and materials to develop business network and prospects
  • Develop relationships with clients, prospect and centers of influence through in-person/virtual calls to understand the needs of the business and its owners and develop the full financial relationship
  • Understand the personal financial goals and needs of the owner(s). Utilize knowledge of personal banking products and partner with Branch, Wealth Management and Private Bank to identify and deliver appropriate personal financial solutions
  • Partner with product specialists to ensure clients are onboarded seamlessly with end-to-end delivery of new accounts and full suite of products and services. Leverage service team to deliver an outstanding client experience
  • Protect the firm by following sound risk management protocols and control policies and adhering to regulatory requirements

Required qualifications, capabilities, and skills

  • Minimum of 5 years’ experience in a Business Banking Relationship Management role or related business lending experience
  • Strong current business network; active involvement in community organizations such as Chambers of Commerce, non-profit boards
  • Demonstrates strong tactical business development and negotiation skills. Self-directed, proactive, and creative; uses sound judgment and navigates ambiguity to get things done
  • Strong relationship-building and excellent communication skills with individuals at all levels, internally and externally. Ability to influence others to achieve desired outcomes and leverage technology to interact with clients effectively and efficiently
  • Strong knowledge of deposit and cash management products and services, and knowledge of business credit underwriting with commercial credit training. Uses seasoned judgment to offer comprehensive and customized solutions that best meet client needs; monitors and researches market/industry trends and business outcomes to anticipate client needs; presents proactive solutions and innovative alternatives when appropriate
  • Balance needs of clients with associated risks and interests of the firm
  • Excellent organizational skills and the ability to manage, prioritize, work under pressure and meet tight deadlines

Preferred qualifications, capabilities, and skills

  • Bachelor’s degree in Finance or related field, or equivalent work experience
  • Minimum of 3 years’ managing clients >$10+MM revenue
  • In-depth knowledge of diverse types of businesses, industries, markets, financial and economic concepts
  • Proficient in Microsoft Office tools including Outlook, Excel, Word, and PowerPoint
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These jobs might be a good fit

17.09.2025
JPM

JPMorgan Business Relationship Manager Senior Deepening - Vice Presid... United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
Manage, retain and deepen a portfolio of approximately 80-100 business clients in stable/mature stage with annual revenue greater than ~$5 million; provide business deposit and cash management solutions and manage...
Description:

As a Business Relationship Manager Senior (BRM) Deepening banker in Business Banking, you’ll be managing a portfolio of large profitable business clients with annual revenue greater than ~$5MM. You’ll focus on deposit acquisition, product deepening, client retention and growth, and gaining referrals to increase primary bank share. As a Senior Deepening banker, you will provide a high-touch experience by building relationships and providing financial advice with a focus on client experience and risk management while deepening existing relationships and leveraging referrals to acquire new relationships.

Job Responsibilities

  • Manage, retain and deepen a portfolio of approximately 80-100 business clients in stable/mature stage with annual revenue greater than ~$5 million; provide business deposit and cash management solutions and manage business credit opportunities up to approximately $15 million; provide support to branch-based business bankers on sizeable business credit deals as needed
  • Deliver an outstanding experience to Chase business clients by providing comprehensive and customized business banking solutions tailored to the financial needs and circumstances of their businesses
  • Use knowledge of business, finance, banking, credit, and risk management to identify, recommend, and promote solutions that best serve the client and ensure the profitability of the portfolio. Leverage knowledge of diverse types of businesses, industries, markets, financial and economic concepts, as well as creative marketing techniques, utilizing Chase resources and materials to develop business network and prospects
  • Regularly conduct in-person/virtual calls with existing clients, referrals and centers of influence at their places of business, looking for ways to cultivate long-term, primary banking relationships
  • Understand the personal financial goals and needs of the owner(s). Utilize knowledge of personal banking products and partner with Branch, Wealth Management and Private Bank to identify and deliver appropriate personal financial solutions
  • Utilize knowledge of treasury products and partner with product specialists to onboard clients seamlessly and ensure end-to-end delivery of new accounts and full suite of products and services; follow up with clients after account opening to determine appropriate additional solutions and establish digital capabilities
  • Protect the firm by following sound risk management protocols and control policies and adhering to regulatory requirements

Required qualifications, capabilities, and skills

  • Minimum of 5 years’ experience in a Business Banking Relationship Management role or related business lending experience
  • Strong knowledge of deposit and cash management products and services, and knowledge of business credit underwriting with commercial credit training. Uses seasoned judgment to offer comprehensive and customized solutions that best meet client needs; monitors and researches market/industry trends and business outcomes to anticipate client needs; presents proactive solutions and innovative alternatives when appropriate
  • Demonstrated ability to anticipate clients’ issues, own problems on clients’ behalf, and follow through with commitments
  • Strong relationship-building and excellent communication skills with individuals at all levels, internally and externally. Ability to influence others to achieve desired outcomes, and leverage technology to interact with clients effectively and efficiently
  • Excellent organizational skills and the ability to manage, prioritize, work under pressure and meet tight deadlines
  • Self-directed, proactive, and creative; uses sound judgment and navigates ambiguity to get things done
  • Balance needs of clients with associated risks and interests of the firm

Preferred qualifications, capabilities, and skills

  • Bachelor’s degree in Finance or related field, or equivalent work experience
  • Minimum of 3 years’ managing clients >$10+MM revenue
  • Proficient in Microsoft Office tools including Outlook, Excel, Word, and PowerPoint
  • In-depth knowledge of diverse types of businesses, industries, markets, financial and economic concept
Show more

These jobs might be a good fit

Limitless High-tech career opportunities - Expoint
Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project...
Description:
Job Summary
In this role, you will provide quality direction, governance, and Quality Management System best practices across the programs you support. This role oversees multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment.
Essential Duties and Responsibilities
  • Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
  • Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
  • Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
  • Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA risk documents, test methods, protocols, reports, manufacturing records, etc.)
  • Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures and ISO standards.
  • Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, document control, change controls, configuration management, etc. Provide direction on any nonconformance, deviation, or excursion that may occur and drive to closure. Author and review product development QMS procedures and work instructions.
  • Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
  • May work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any other necessary quality records. Provide quality reports and review trending on assigned areas of responsibility.
  • May support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
  • May assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process Statistical Process Control programs.
  • May perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols, and identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed.
  • May have people management responsibilities.
  • Other duties as assigned.
Education
  • Bachelor's Degree in Engineering or Science or equivalent experience required
Work Experience
  • Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities required and
  • Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required and
  • In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971 required and
  • Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required and
Preferred Knowledge, Skills and Abilities
  • Experience with MasterControl, SAP, Share Point, Teamcenter
  • Experience with ISO 11040, ISO 11607
  • Expertise in quality management tools. Standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
  • Strong working knowledge of quality systems of the respective ISO norms
  • Working knowledge of supplier quality management from product development to mass production.
  • Strong project management skills
  • Proficient in computer system applications (SAP, master controls, etc) communication skills
  • Excellent critical reading and writing skills
  • Problem solving including root cause failure analysis methods
  • Be aware of all relevant SOPs as per Company policy as they relate to this role
  • Able to comply with the company’s safety and quality policies at all times
Additional Requirements
  • Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
  • Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
  • Ability to work independently, multi-task and thrive in fast-paced environment.
  • Strong problem-solving skills including root cause failure analysis methods.
  • Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
  • Must maintain the ability to work well with others in a variety of situations.
  • Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Ability to make independent and sound judgments.
  • Observe and interpret situations, analyze and solve problems.
License and Certifications
  • Manufacturing\Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
  • Quality\Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred
  • SO 17025 Auditor or Lead Auditor Training / Certification Upon Hire preferred
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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