Sr Quality Manager

San Diego, California

Work Arrangement: In Office
2021-11-08

Sr Quality Engineering Manager – Medical Device
A leading designer, developer, and manufacturer of medical devices is seeking a talented Sr QA Engineering Manager to work as a hand on manager and lead fellow QA professionals and QC inspectors.

What you will do:

  • Assist and support the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
  • Perform evaluations of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
  • Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.

Who you are:

  • Experience interacting with federal authorities such as US FDA is required
  • Strong understanding of ISO 13485, 21 CFR 820 and quality system
  • Strong understanding of compliance processes in a medical device environment such as non-conforming products, CAPA, suppliers monitoring, calibration, preventative maintenance and internal audit
  • Typically requires a Bachelor degree in Science with 3 years of management experience
Why work here:
  • Added stock options as part of our compensation package within the 90 days
  • Great team and culture with work life balance.
  • Opportunity to make an impact and help effect change and new processes.
  • Company promotes internally.
Please email your resume to sshields@provenrecruiting.com if you’d like to work alongside some of the finest scientists in the Life Sciences industry!

Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

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