Quality Engineer

Minneapolis, Minnesota Quality Engineering 4 days ago

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Job Summary:
Seeking a Manufacturing Quality Engineer II with medical device industry experience to manage supply chain quality processes and ensure compliance with regulatory standards.

Job Requirements:

  • Bachelor’s Degree in Engineering or a technical field
  • 2-5 years of experience in Quality Engineering within the Medical Device industry
  • Knowledge of 21 CFR 820 regulations
  • Experience with change control, non-conformance, and CAPA processes
  • Strong experience in supplier change control
  • Proficiency in statistical data analysis techniques

Preferred Skills:

  • Experience in PFMEA (Process Failure Mode and Effects Analysis)
  • Ability to develop, review, and approve test plans and reports

Job Responsibilities:

  • Manage and maintain quality processes in a medical device manufacturing environment
  • Investigate and collaborate on atypical events to support product disposition
  • Ensure compliance with supplier change control processes
  • Analyze data using statistical techniques to support product quality
  • Oversee change control and non-conformance investigations in line with CAPA processes


Pay Details: $50.00 to $55.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance
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