Manufacturing Quality Engineer II - Medical Devices

JCW Group; Minneapolis, Saint Paul (MN, MN); On-site; USD 85,000 - 110,000; Full time

Job summary

JCW Group is seeking a Manufacturing Quality Engineer II to own operations quality across programs from development into commercial production. On the floor, you will drive compliant builds, close real problems, and serve as the quality point of contact.

Role requires strong knowledge of 21 CFR Part 820, ISO 13485, and PLM tools (Windchill/Agile/Propel). You will support QC activities, review documentation, and trend metrics for leadership insight.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Nonconformance management

CAPA management

Root cause analysis

Quality tools

Quality engineering

Education

Bachelor's degree in life science

Tools

Windchill

Agile

Propel

Minitab

Job description

JCW Group is seeking a Manufacturing Quality Engineer II to own operations quality across programs from development into commercial production. On the floor, you will drive compliant builds, close real problems, and serve as the quality point of contact.

Role requires strong knowledge of 21 CFR Part 820, ISO 13485, and PLM tools (Windchill/Agile/Propel). You will support QC activities, review documentation, and trend metrics for leadership insight.