Quality Engineer
$72,000–$114,000 year
On-site · Plymouth, Minnesota, United States
Job Summary
Quality Engineer leads representation for assigned product lines in new product development and day-to-day manufacturing support, drives CAPA and non-conformance investigations, and ensures compliance with GMP/quality standards (21 CFR 820, 210, 211 and ISO 13485). Partners with Operations and Engineering to implement production processes, conducts data analysis and reporting, supports supplier quality and internal audits, and develops/processes for qualification, validation, PFMEA creation, and continuous improvement to meet customer requirements and company objectives. Requires an engineering/science degree with a background in the medical device field, knowledge of regulatory standards, and strong communication, problem-solving, and interpersonal skills. 1st shift; Plymouth, MN based (on-site).
Required Qualifications
- Engineering/Science degree with drug/medical device-related background
- minimum of 3 years’ experience in the field
- Experience in the Medical/Cleanroom industry
- Knowledge of medical device regulation (21 CFR 4, 210, 211, 820), QMS ISO 13485, risk management (ISO 14971)
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, Project)
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