Hiring: Manufacturing Engineer Company: JCW Group Location: Greater Minneapolis-St. Paul Area Job Posted Time: 2026-09-03 10:34:05 Employment Type: Contract Target Skills & Keywords : Agile About the job Experience: •5+ years in medical device development or manufacturing, or 3+ years in a Design Assurance or Quality Engineering role Required Skills: •Serve as a core team member accountable for operations quality deliverables across the product lifecycle •Manage nonconformances and CAPAs from initiation through effectiveness verification, leading root cause analysis with structured methods (5-Why, fishbone) •Provide quality oversight for IQ/OQ/PQ activities, reviewing and approving protocols, reports, and change orders •Own incoming inspection approvals, disposition nonconforming material, and coordinate supplier corrective actions •Review batch records and travelers for GMP compliance, and support line clearances and first-article inspections •Author and approve SOPs, work instructions, and forms, and keep Design History Files accurate and audit-ready •Compile and trend quality metrics, then present actionable insights to leadership Qualifications: •Bachelor's degree in a life science discipline, or an equivalent mix of education and experience •Hands-on experience within 21 CFR Part 820 and ISO 13485 quality systems •Strong command of quality tools: nonconformance management, CAPAs, and root cause analysis Compensation: •$80,000 - $105,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!