About the role
Manufacturing Engineer II
Second shift, 4x10s (approx. 3:30 PM to 1:30 AM)
A growing medical device contract manufacturer is looking for a Manufacturing Quality Engineer II to own operational quality across programs moving from development into commercial production. If you like being the quality point of contact on the floor, driving compliant builds, and closing out real problems rather than just documenting them, this one is worth a look.
What you'll do
- 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
What you'll bring
- Bachelor's degree in a life science discipline, or an equivalent mix of education and experience
- 5+ years in medical device development or manufacturing, or 3+ years in a Design Assurance or Quality Engineering role
- 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
- Experience with PLM software (Windchill, Agile, or Propel); Minitab familiarity a plus
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