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Quality Engineer

San Diego, CA

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Description

RemX is hiring experienced Quality Engineers for long-term contract roles supporting a leading developer of in vitro diagnostics and other medical device products.  Quality Engineers will support legacy product lines as well as new products and processes in ensuring overall compliance with FDA and ISO regulations as well as customer requirements.  Multiple positions available for QE’s from mid to senior level.

 

These are long-term contract positions expected to last 18 months or longer.  Successful candidates should have a solid background in medical device manufacturing, including knowledge of 21 CFR 820 and ISO 13486, and excellent communications and organizational skills.

 

Primary Responsibilities:

  • Serve as Quality representative on Design Transfer, Design Control, and Product Improvement teams
  • Perform root cause analysis of product quality issues and develop corrective and preventative actions (CAPA)
  • Perform failure mode analysis on new or legacy products; support the development of mitigations for failure modes and verify the effectiveness of these mitigations
  • Develop, execute and document verification and validation plans that assess if requirements are met
  • Sr. Quality Engineers will lead complex, cross-functional projects which may include the creation of project plans, timelines and responsibilities matrix

Job Requirements

  • Bachelor’s Degree in Engineering, Biotechnology, or a related scientific or engineering field
  • 3 or more years’ related Quality experience in the medical device field
  • Working knowledge of regulatory requirements and quality systems (21 CFR Part 820, ISO 13485, ISO 14971:2012, CMDR)
  • Working knowledge of process validation and design control
  • Experience in root cause analysis and corrective action processes
  • Working knowledge of the technical aspects of in-vitro diagnostic device functions
  • ASQ Certified Quality Engineer or equivalent preferred
  • Ability to travel up to 20%, domestic and internationally

 

Additional Information

Location: San Diego, CA

Position Type: Contract

Pay Range: Negotiable based on experience

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