Quality Engineer II

Location: Dexter, MI (Onsite) Duration: 12 Months
Job Id : 24930 Pay: $40–$50/hr

Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control .

• 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 )

• 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

• CSV (Computer System Validation)
• SOP development
• Inspection sampling plans
• Packaging validation
• Change control (medical devices)

• 2+ years Quality/Validation experience
• Medical device experience preferred (MDR a plus)
• Bachelor’s in Engineering (Quality/Mechanical/Biomedical/Industrial)