Agile PLM / Oracle PLM (Product Lifecycle Management), Biomedicine, Change Control, Change Requests/Orders, Computer Systems, Healthcare Quality, Manufacturing, Manufacturing Analysis, Medical Equipment, Medical Products, Minitab, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Production Support, Quality Assurance Methodology, Quality Engineering, Risk Analysis, Risk Management, Sampling Inspection, Standard Operating Procedures (SOP), System Validation, United States Department of Energy (DOE), Validation Documentation, Validation Testing, Warehousing
Job Title: Quality Engineer II
Location: Dexter, MI (Onsite)
Duration: 12 Months
Job Id: 24930
Pay: $40–$50/hr
Role Summary
Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control.
Top Skills (Must Have)
- Process Validation (IQ, OQ, PQ)
- Validation lifecycle (process characterization → PQ)
- Test method validation & documentation
- PFMEA, Control Plans, risk documentation
- FAI, dimensional inspection, manufacturing change evaluation
- DOE experience (Minitab preferred)
Key Responsibilities
- Execute process & test method validations (IQ/OQ/PQ)
- Perform First Article Inspections (FAI) and reporting
- Develop PFMEA, Control Plans, risk assessments
- Support MDR remediation activities
- Conduct packaging/fit testing and validation
- Review and approve change orders (Agile PLM)
- Perform label verification and production support
- Collaborate with manufacturing, engineering, warehouse teams
Additional Skills
- CSV (Computer System Validation)
- SOP development
- Inspection sampling plans
- Packaging validation
- Change control (medical devices)
Experience Required
- 2+ years Quality/Validation experience
- Medical device experience preferred (MDR a plus)
- Bachelor’s in Engineering (Quality/Mechanical/Biomedical/Industrial)