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Senior Vice President jobs in United States, Arizona, Tempe

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Job type
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Job title (1)
United States
Arizona
Tempe
62 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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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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18.09.2025
JPM

JPMorgan Risk Management - Special Credits Lead Vice President United States, Arizona, Tempe

Limitless High-tech career opportunities - Expoint
Review existing collateral and loan documentation to identify errors, omissions, or other deficiencies, and remediate as needed and to the extent possible. Obtain current financial information and collateral valuation(s) in...
Description:

As a Special Credits Officer - Vice President in Business Banking Risk, you will focus on risk-managing and maximizing the recovery of the bank’s credit exposure through early intervention in dealing with stressed/distressed borrowers or obligors. You will manage and service a problem credit portfolio of small business client relationships with an aggregate exposure greater than $500,000. You will play a key role in identifying credit issues early, allowing the bank to mitigate risk and help manage deteriorating exposure.

Job responsibilities

  • Review existing collateral and loan documentation to identify errors, omissions, or other deficiencies, and remediate as needed and to the extent possible.
  • Obtain current financial information and collateral valuation(s) in accordance with procedures, and evaluate client's financial strength / capacity and collateral to repay outstanding debt.
  • Assess client and facility risk ratings in accordance with procedures.
  • Determine stay / leave strategy for individual clients, and develop / implement a plan of action to protect and improve the bank's position in the credit.
  • Negotiate satisfactory restructure of credit facilities and obtain additional collateral as appropriate.
  • Monitor progress in accordance with approved strategy, and timely document systems to reflect current status.
  • Initiate appropriate legal action when necessary to protect interests of the bank, including litigation and liquidation / foreclosure of collateral.
  • Document all contact, agreements and discussions that transpire with the client, outside vendors and attorneys.
  • Timely submission of loans to the Small Business Administration (SBA) for repurchase when the defaulted credit facility is enhanced with a SBA guarantee.

Required qualifications, capabilities, and skills

  • 5+ years of commercial collections and workout loan experience
  • Strong working knowledge of financial statement analysis, standard accounting practices, accounts receivable/borrowing base analysis, and collateral perfection
  • Expert understanding of commercial real estate and accounts receivable / inventory lending.
  • Strong functional and technical skills: Negotiation and influencing skills, written and verbal communication, decision quality, conflict management, interpersonal, and analytic / problem solving skills.
  • Expert knowledge of credit philosophy, policies & procedures, loan documentation, SBA, collections litigation, federal bankruptcy laws, and state collection laws.
  • Excellent verbal and written communication skills.
  • Excels in high pressure situations and thrives in fast paced environments.
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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

17.09.2025
JPM

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

Limitless High-tech career opportunities - Expoint
Lead the strategic development and implementation of the sales enablement platform. Collaborate with sales, marketing, and technology teams to align platform capabilities with business goals. Drive the adoption and utilization...
Description:

Job responsibilities

  • Lead the strategic development and implementation of the sales enablement platform
  • Collaborate with sales, marketing, and technology teams to align platform capabilities with business goals
  • Drive the adoption and utilization of sales tools and resources to enhance sales effectiveness
  • Develop and deliver training programs to equip the sales team with the necessary skills and knowledge
  • Analyze sales performance data to identify trends and opportunities for improvement
  • Foster a culture of continuous learning and development within the sales team
  • Ensure seamless integration of the sales enablement platform with existing systems and processes
  • Monitor industry trends and best practices to keep the platform competitive and innovative
  • Engage with senior leadership to communicate platform impact and strategic direction
  • Manage vendor relationships and oversee platform enhancements and updates
  • Champion a client-centric approach to sales enablement, ensuring alignment with client needs and expectations

Required qualifications, capabilities, and skills

  • Minimum of 10 years of experience in asset management or a related field
  • Proven track record in leading sales enablement or marketing initiatives
  • Effective leadership and team management skills
  • Excellent communication and presentation abilities
  • In-depth understanding of sales processes and tools
  • Ability to analyze data and derive actionable insights
  • Experience in managing cross-functional projects and teams
  • Proven strategic thinking and problem-solving skills
  • Proficiency in CRM and sales enablement platforms
  • Ability to work effectively in a fast-paced, dynamic environment
  • Commitment to fostering a diverse and inclusive workplace

Preferred qualifications, capabilities, and skills

  • Experience in the Hong Kong or APAC asset management market
  • Familiarity with Salesforce or similar CRM systems
  • Advanced degree in marketing, business, or a related field
  • Experience in digital marketing and client engagement strategies
  • Large network within the asset management industry
  • Ability to influence and drive change across diverse teams
  • Passion for leveraging technology to enhance sales and marketing efforts
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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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