Job Description: Our client is looking for a hands-on Senior Quality Engineer to support day-to-day production and process control activities in a medical device manufacturing environment. This is a manufacturing quality role focused on process execution and is not a design quality or supplier quality position.
The ideal candidate will have strong experience with electromechanical medical devices. IVD experience is a plus. This person should be comfortable owning documentation, supporting validations, and working closely with manufacturing on the floor.
Responsibilities: Day-to-day quality engineering support for manufacturing operations
Production and process controls
Process Validation and TMV
PFMEA and management of CPQs/CTQs
Authoring and updating protocols, reports, CAPAs, and PFMEAs
Partnering with Manufacturing Engineering, Validation, and Operations
Requirements: Around 10 years of quality engineering experience in medical device manufacturing
Strong hands-on experience in production/process quality
Background supporting electromechanical devices
Experience with Process Validation, TMV, PFMEA, CAPA, and CPQs/CTQs
Strong documentation experience in regulated environments
Able to work at the execution level and support day-to-day manufacturing quality needs
Pluses: IVD product experience
Experience with Agile PLM System
*Ideal Candidate:* Hands-on, practical, and execution-focused
Strong writer who can develop quality documentation independently
Comfortable working cross-functionally in a fast-paced manufacturing environment
Salary:
The hourly rate for this position is $52 $59/Hr on W2, depending on experience and qualifications.
Benefits:
Eligible employees may have access to benefits offered by Novozen Healthcare LLC in accordance with the applicable benefit plans and eligibility requirements.
Equal Employment Opportunity:
Novozen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Background Check:
Background checks may be conducted in accordance with applicable law.