Quality Engineer - Contract Manufacturing

Quality Engineer

Manpower Engineering is partnering with a leader in medical device contract manufacturing for a Quality Engineer. Job Title: Quality Engineer Location: Vadnais Heights Pay: $85,000 - $100,000 plus bonus potential Direct Hire

Key Responsibilities:

• Supports development and sustaining quality activities for assigned programs, including part validation, qualification, and ongoing compliance.
• Participates in the organization's Stage-Gate approach to product realization.
• Supports and executes validation activities, including IQ, OQ, and PQ protocols and reports, as directed.
• Carries out quality planning activities including Process Flow Diagrams, Process FMEAs, and Control Plans. Prepares work instructions and inspection instructions.
• Acts as the primary quality contact for assigned customers, supporting customer quality concerns, investigations, and corrective actions.
• Participates in the creation and management of CAPAs, SCARs, RMAs, and sustaining programs.
• Supports disposition of internally produced nonconforming material.
• Works collaboratively with Manufacturing, Engineering, and Supply Chain to provide consultation and guidance on quality issues.
• Serves on the internal audit team and leads customer audits for assigned programs and products, including audit preparation, participation, documentation, and coordination of responses and corrective actions, while supporting ISO 13485 and regulatory audits as assigned.
• Drives continuous improvement by analyzing quality data, identifying trends, and partnering with cross-functional teams to improve product and process performance.

Qualifications and Skill Requirements:

• B.S. Degree in Engineering or equivalent work experience required.
• 4+ years' experience in a regulated manufacturing environment.
• Experience executing IQ, OQ, and PQ validation activities.
• Working knowledge of ISO 13485 and applicable FDA quality system requirements.
• Experience supporting customer audits and quality discussions.
• Strong root cause analysis and corrective action experience.
• Ability to manage multiple projects concurrently.
• Strong understanding of print reading, cGMP/cGDP, GD&T, and cosmetic specifications.
• Experience with Epicor or similar ERP systems preferred.
• Experience with change control, revision control, and documentation.

Benefits:

• Medical Plan
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long-Term Disability Insurance
• Accrued PTO
• 401(k)

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells