Senior Principal Quality Engineer
$120,000–$165,000 year
On-site · Oakdale, Minnesota, United States
Job Summary
Senior Principal Quality Engineer leading quality support for drug product and medical device R&D activities, acting as the on-site Quality SME for lab-related activities, ensuring compliance with international regulations (EU MDR) and the Vantive QMS, reviewing and approving site QMS documentation, supporting audits (internal and external), and managing nonconformance investigations and CAPA.location is onsite at least 3 days per week in Oakdale, MN, with duties spanning verification/validation, equipment qualification, training plans, change control, and harmonization of QMS practices across R&D sites. Requires a Bachelor's degree in a related field and 6+ years of relevant experience, with familiarity in GLP/GMP and a solid understanding of quality engineering principles and regulatory standards. The role emphasizes collaboration across cross-functional teams and a focus on maintaining high-quality documentation and processes for regulated drug product and medical device activities.
Required Qualifications
- Bachelor's Degree in a related field
- 6+ years of relevant experience in medical device or pharmaceutical industry or similarly regulated industry
- 5+ years in analytical chemistry or microbiology lab support for regulated products
- Familiarity with GLP/GMP
- Ability to work independently and promote QMS compliance
- Experience with EU GMP (EudraLex Vol 4) and ISO 13485 highly preferred (optional)
- Auditing experience or training preferred
- Strong communication skills and cross-functional collaboration
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