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Medical Device Quality Engineer

Aerotek Irvine, CA
  • Expired: 29 days ago. Applications are no longer accepted.

We are looking for a quality engineer with proven successful experience in the medical device industry.

The role sstablishes quality standards for products and processes and suggests modifications meant to prevent defects in components or final products. Works closely with cross-functional teams including product design, product management, and production to identify and mitigate quality risks. Audits production processes, raw materials or suppliers/vendors to ensure that established quality standards are met. Conducts root cause analysis for defects nonconformities or other quality failures. May be responsible for ensuring compliance with formal external quality standards such as ISO 9001.

Skills

  • CAPA, Investigations, NCMR, Compliance, Quality Assurance, Engineering, FDA, Pharmaceutical, Medical Device

Job Title

  • Sr. Quality Engineer

Top Skills Details

  • Writing CAPA's
  • Adhering to FDA/ISO/GMP requirements
  • Performing risk mitigation
  • Providing NCMRs
  • Analyzing product discrepancies

Additional Skills & Qualifications

  • Data integrity, compliance, CFR requirements
  • 2 years or more experience

Additional Information

  • These positions are open due to additional CAPA projects/discrepancies in manufacturing.
  • This work will be ongoing for the Irvine site.
  • Will be responsible for preventing backlog in the quality department.
  • Will support investigations along with several business units within the quality.

Job Description

  • The Quality Assurance Engineer will be responsible for establishing quality standards for products and processes and suggests modifications meant to prevent defects in components or final products.

Work Environment

  • Will be working in a manufacturing setting. 20 members on the team.
  • Client is in a growth state and is the recognized market leader in their product space. There is significant opportunity for this assignment to last up to a year and beyond for the right candidate.

Additional Skills

  • CAPA, Investigations, NCMR, Compliance, Quality Assurance, Engineering, FDA, Pharmaceutical, Medical Device

Aerotek

Address

Irvine, CA
USA