Quality Engineer II
Location
Dexter, Michigan
Job Type
Full-time
Category
other-general
Posted
May 16, 2026
Job Summary:
Roles & Responsibilities:
- Quality Engineer II with experience in medical device manufacturing, process validation, and quality systems compliance within FDA-regulated and EU MDR environments. Skilled in IQ/OQ/PQ validation, process characterization, PFMEA, control plans, risk management, SOP development, and change control activities.
- Experienced in supporting process validation lifecycle activities, test method validations, dimensional verification, FAIs, and manufacturing process improvements while ensuring compliance with ISO 13485, ISO 14971, IEC 60601, and FDA 21 CFR Part 820 requirements.
Roles & Responsibilities:
- Support and execute process validation lifecycle activities including Process Characterization, IQ, OQ, and PQ validations.
- Develop, review, and execute validation protocols, reports, SOPs, and test method validation documentation.
- Perform equipment qua...