Senior Quality Engineer jobs at West Pharma in United States, Tempe

• Provide engineering assistance to assure plant, machinery and processes are at an optimum level.
• Demonstrated experience in Metal Stamping and Progressive Die industry.
• Ensure plant is in compliance with OSHA and local, state and federal environmental regulations.
• Assist in Writing validation, user requirements, equipment specification and other documents as needed.
• Promote and support a Lean Manufacturing environment within the facility.
• Assist in process and procedure improvements to manufacture a quality product at a minimum cost.
• Assists in quoting new tooling/dies, engineering services, automation, etc. for new and existing customers. Helps Develop suppliers and maintain audit. Develops design concepts for new molds.
• Purchases tooling related equipment in accordance with the company policy.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain machine and plant equipment drawing for the Tool Room.
• Support in Developing initial project scope, timeline, savings and cost estimations.
• Write CER and project justification documents.
• Support in Developing equipment requirements.
• Research new technologies and methodologies to use in the plant.
• Present justification to management and/or customer to attain approvals.

• Performs other duties, as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, or equivalent experience required

• Minimum 3 years of relevant experience. Prior manufacturing experience in an industrial setting (pharmaceutical industry experience preferred). required
• Advanced in using SolidWorks. required
• Excellent computer skills required including all MS Office applications. required

• Good understanding in machining and fabrication equipment and methods (e.g. milling, turning, grinding, eroding, etc.).
• Familiar with cGMP, ISO, and FDA standards.
• Familiar with AutoCAD, Finite Element Analysis, Computational Fluid Dynamics, and PDM Pro.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

• Must be able to negotiate and effectively resolve conflicts when required
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Ability to quickly adapt to changes in a dynamic environment and must maintain the ability to work well with others in a variety of situations
• Effective personal time management skills. 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
• Must be able to speak English fluently

• 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.

• Bachelor's Degree in Engineering or Science or equivalent experience required

• 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

• 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

• 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.

• 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

• 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.

• Bachelor's Degree In Engineering or Science field required
• Master's Degree In Engineering or Science field preferred

• 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

• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• 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

• Must be able to perform job duties as required with limited physical demands.

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
• Understand and follow applicable ISO standards requirements
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site
• Generate rejection and deviation reports as directed by site
• Perform trace back investigation of nonconforming raw material and product as directed by site
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules
• Exhibits regular, reliable, punctual and predictable attendance
• Other duties as assigned

• High School Diploma or GED Required

• Minimum one year manufacturing experience required

• Must poses an acute attention to detail
• Basic computer skills

In this role, you will monitor and control the daily activities of quality inspection, testing, documentation review, and calibration in support of Operations and product release. This role is on-site (Monday through Friday) from 10:00 pm to 6:00 am.

• Able to train, provide trouble shooting guidance/feedback, and problem resolutions on metrology equipment including but not limited to CMM’s (Coordinate Measurement Machine), Vision Systems, and manual gaging.
• Proactively analyze data and interpret results for any trending or OOS (out of specification) events.
• Provides direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize quality inspection, testing, documentation review, and calibration to support Operations and release of product.
• Identifies and develops opportunities to improve existing processes and procedures.
• 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.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Assist in and manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished. Advise on equipment condition, test method, etc. to aid in the course of action when components do not meet specifications. Responsible for quality inspection and verification.
• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non‐Conformance Report is required.
• Assist in developing documentation and procedures during the qualification of new equipment/inspection methods.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance .

Education or Equivalent Experience: Associate’s Degree in Technical or Engineering

• 5+ years experience in regulated Quality Assurance and or metrology and Document/Configuration Control (or a formal education equivalent) required.
• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Metrology/Manufacturing background and Risk Management preferred.
• Experience with quality systems such as ISO 13485 and 21 CFR 820 preferred.
• Experience with MasterControl, SAP, and SharePoint preferred.
• Experience with customer interface and meeting customer expectations preferred.
• 3+ years of supervisor experience preferred.

• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills.
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.
• Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.
• Familiarity with root cause analysis tools.
• Working knowledge of MasterControl and SAP.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual.
• Able to comply with the company’s safety policy at all times.

• 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.
• 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.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.

• 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.

• Bachelor's Degree in Engineering or Science or equivalent experience required

• 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

• 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

• 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

• 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.