MDR - Quality Engineer II

Job Title: MDR - Quality Engineer II
Location: 2555 Bishop Circle W Dexter Michigan 48130 (Onsite)
Duration: 12 Months
Job ID: 26482
Pay Range: $50-55/hr on W2

Role Summary
Quality Engineer supporting MDR remediation and manufacturing quality assurance across medical device product lines at the Dexter site (onsite role). Focus is on ensuring process validation, risk management, and compliance of manufacturing, labeling, and packaging activities with internal and regulatory requirements.

Core Responsibilities
Perform First Article Inspections (FAIs) and documentation
Develop and maintain PFMEA, Control Plans, and risk management files
Support process validation and test method validation activities
Conduct floor audits and production process observations
Evaluate and document packaging, labeling, and manufacturing changes
Review and approve change orders (Agile PLM)
Perform label verification, dimensional checks, and product testing support
Coordinate with manufacturing, engineering, warehouse, and product teams
Maintain compliance documentation and MDR remediation records

Top Required Skills
Process validation & test method validation
PFMEA, Control Plans, risk documentation
FAI, dimensional inspection, packaging/manufacturing change evaluation

Experience Required
Bachelor’s in Engineering (or related field)
2+ years experience (4+ preferred) in quality/validation
Medical device / MDR experience strongly preferred

Work Setup
Onsite role (Dexter, MI)
40 hours/week
Supports multiple product lines at site