Jobility Talent Solutions
Senior Quality Engineer - Medical Devices/Pharmaceutical Manufacturing
Jobility Talent Solutions, Sturtevant, Wisconsin, United States
Senior Quality Engineer - Medical Devices/Pharma
Sturtevant, WI
100% Onsite 6-Month Contract (W2 Only)
About the Role We are seeking a Quality Engineer to support Operations, Sustaining Engineering, R&D, and New Product Introduction teams. The role focuses on Change Control, CAPA, Design Control, Risk Management, Post-Market Surveillance, and Quality System compliance within a medical device environment.
Key Responsibilities Support and review Change Control activities for Operations, Engineering, and Design teams Review technical documentation for accuracy and compliance Assist with verification, validation, and introduction of product changes and new products Support supplier quality activities and drive quality improvement initiatives Lead/support CAPA investigations, nonconformance analysis, deviations, scrap/rework analysis Contribute to Risk Management activities and updates to risk files Support regulatory inspections and internal/vendor audits Ensure adherence to FDA QSR, ISO 13485, GMP, and other medical device regulations Provide support to Quality Management and cross-functional teams as needed
Minimum Qualifications Bachelors degree in Engineering, Physical Sciences, or equivalent 35 years
of Quality Engineering experience 67 years
in Medical Device, Pharmaceutical, or similar regulated industries Strong knowledge of: Quality Systems (ISO 13485, FDA QSR) CAPA & Nonconformance investigations Change Control & Documentation review Risk Management principles Technical writing & analysis
Preferred Qualifications Experience with electromechanical devices ASQ Certified Quality Engineer (CQE) or equivalent Familiarity with statistical sampling for DV/PV Experience with system software/firmware/hardware integration
Technical Skills Microsoft Office Suite (Word, Excel, PowerPoint, Visio) Adobe Quality System Management Software Strong analytical and problem-solving skills Effective communication and the ability to work with minimal supervision
100% Onsite 6-Month Contract (W2 Only)
About the Role We are seeking a Quality Engineer to support Operations, Sustaining Engineering, R&D, and New Product Introduction teams. The role focuses on Change Control, CAPA, Design Control, Risk Management, Post-Market Surveillance, and Quality System compliance within a medical device environment.
Key Responsibilities Support and review Change Control activities for Operations, Engineering, and Design teams Review technical documentation for accuracy and compliance Assist with verification, validation, and introduction of product changes and new products Support supplier quality activities and drive quality improvement initiatives Lead/support CAPA investigations, nonconformance analysis, deviations, scrap/rework analysis Contribute to Risk Management activities and updates to risk files Support regulatory inspections and internal/vendor audits Ensure adherence to FDA QSR, ISO 13485, GMP, and other medical device regulations Provide support to Quality Management and cross-functional teams as needed
Minimum Qualifications Bachelors degree in Engineering, Physical Sciences, or equivalent 35 years
of Quality Engineering experience 67 years
in Medical Device, Pharmaceutical, or similar regulated industries Strong knowledge of: Quality Systems (ISO 13485, FDA QSR) CAPA & Nonconformance investigations Change Control & Documentation review Risk Management principles Technical writing & analysis
Preferred Qualifications Experience with electromechanical devices ASQ Certified Quality Engineer (CQE) or equivalent Familiarity with statistical sampling for DV/PV Experience with system software/firmware/hardware integration
Technical Skills Microsoft Office Suite (Word, Excel, PowerPoint, Visio) Adobe Quality System Management Software Strong analytical and problem-solving skills Effective communication and the ability to work with minimal supervision