Quality Engineer - Medical Devices

Type: 6-Month Contract-to-Hire

Job Summary: Seeking a Quality Assurance Engineer to support quality systems, manufacturing operations, CAPA, validation, audits, and DHF activities within a medical device environment. This role will partner cross-functionally to ensure compliance with FDA and ISO standards throughout the product lifecycle.

Key Responsibilities: Manage CAPAs, nonconformances, root cause investigations, and change controls Support IQ/OQ/PQ validation activities and review quality documentation Maintain DHF documentation and support product lifecycle activities Review batch records, work orders, and manufacturing documentation for GMP compliance Support incoming inspection, supplier quality, and audit readiness Analyze quality metrics and drive continuous improvement initiatives Support customer complaint investigations and PLM system updates

Required Qualifications: Bachelor s degree in Engineering, Life Sciences, or related field 5+ years of medical device quality or design assurance experience Strong knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971 Experience with CAPA, NCs, DHF, audits, and validation activities Familiarity with PLM systems such as Windchill, Agile, or Propel