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Quality Engineer
Quality EngineerKatalyst CRO • Minneapolis, MN, US
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Quality Engineer

Quality Engineer

Katalyst CRO • Minneapolis, MN, US
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Job Description

Quality engineer experienced with internal or external auditing to internal QMS requirements; understands 21 CFR 820, ISO 13485, and CGMP Regulations.

Contract duration would be 2 years.

Responsibilities

  • Understand Client's QMS requirements at a detail level.
  • Review Product and QMS documentation to evaluate compliance.
  • Maintain an internal audit schedule.
  • Assist in communicating internal audit agendas and scheduling.
  • Participate in internal audits.
  • Generate Internal Audit reports.
  • Review and approve product and QMS work products as required.
  • General Quality Engineer tasks as required.

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Quality Engineer • Minneapolis, MN, US

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