Michael Page
Senior QA Systems Engineer - Medical Device - Methuen, MA
Michael Page, Methuen, Massachusetts, us, 01844
Impactful work - in this role you will contribute to life-saving technologies
Work at an organization that is at the forefront of medical technology
About Our Client
My client is a leading innovator in the field of medical technology, with an extremely specialized product line. The company is known for its commitment to advancing healthcare through cutting-edge technology and a mission-driven culture that prioritizes improving patient outcomes and saving lives.
Job Description
Manage and improve the Quality Management System (QMS) in compliance with regulatory standards. Lead Corrective and Preventive Actions (CAPA) processes and ensure timely resolution. Plan, conduct, and support internal and external audits. Analyze quality metrics and drive continuous improvement initiatives. Perform root cause analyses using tools like FMEA and DOE. Support risk management activities, including risk reviews and mitigation plans. Oversee supplier quality and ensure effective controls are in place. Collaborate cross-functionally with quality, operations, and regulatory teams. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
BS in Engineering, Quality or other relevant discipline 8+ years of quality experience in the medical device industry Working knowledge of ISO 13485:2016, FDA and other quality systems Hands on CAPA System, Non-conformity System, Root Cause investigation and manufacturing process improvement experience Experience with complex medical device products, medical capital equipment and electromechanical devices preferred. Ability to communicate ideas and information clearly, effectively, and concisely. Strong computer skills What's on Offer
Impactful work Cutting-Edge Technology Collaborative Environment Career Development Work-life balance Competitive compensation and benefits package
Contact
Taylor Rankin
Quote job ref
JN-072025-6786900
My client is a leading innovator in the field of medical technology, with an extremely specialized product line. The company is known for its commitment to advancing healthcare through cutting-edge technology and a mission-driven culture that prioritizes improving patient outcomes and saving lives.
Job Description
Manage and improve the Quality Management System (QMS) in compliance with regulatory standards. Lead Corrective and Preventive Actions (CAPA) processes and ensure timely resolution. Plan, conduct, and support internal and external audits. Analyze quality metrics and drive continuous improvement initiatives. Perform root cause analyses using tools like FMEA and DOE. Support risk management activities, including risk reviews and mitigation plans. Oversee supplier quality and ensure effective controls are in place. Collaborate cross-functionally with quality, operations, and regulatory teams. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
BS in Engineering, Quality or other relevant discipline 8+ years of quality experience in the medical device industry Working knowledge of ISO 13485:2016, FDA and other quality systems Hands on CAPA System, Non-conformity System, Root Cause investigation and manufacturing process improvement experience Experience with complex medical device products, medical capital equipment and electromechanical devices preferred. Ability to communicate ideas and information clearly, effectively, and concisely. Strong computer skills What's on Offer
Impactful work Cutting-Edge Technology Collaborative Environment Career Development Work-life balance Competitive compensation and benefits package
Contact
Taylor Rankin
Quote job ref
JN-072025-6786900