Senior Design Quality Engineer

Senior Design Quality Engineer

13 Jun 2024
California, Pomona, 91766 Pomona USA

Senior Design Quality Engineer

Vacancy expired!

For all interested candidates, please send your resume to Caitlyn Opulencia at

Senior Design Quality Engineer (contract to hire) - Pomona, CA

RESPONSIBILITIES

  • Lead quality assurance support in the design and development/on market support of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.
  • Create and maintain risk management files such as UMFMEA/DFMEA/PFMEA that identify Hazard Analysis Critical Control Points (HACCP) and are compliant with the requirements of ISO 14971:2012.
  • Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues.
  • Lead and support multiple projects, balancing priorities and resources to meet project and management expectations.
  • Review and approve proposed changes for on market products by performing risk
  • assessments, providing guidance and support and assessing the adequacy of verifications and validations and DMR documents.
  • Resolve QI and CAPA by performing investigations, conducting root cause analysis, developing and implementing plans to resolve.
  • Review and approve verification and process validation, equipment qualification documents.
  • Lead process improvement projects
  • Act as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation etc.


BASIC QUALIFICATIONS
  • Minimum of 5 years of following experience with Bachelor's degree in field of Science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering, OR Master's degree and 3 or more years of relevant experience:
  • Quality Assurance engineering experience (design controls, change control, process validation, on market quality engineering support and risk management)
  • Hands on CAPA System, Non-conformity System, Root Cause investigation and manufacturing process improvement experience
  • Hands-on risk management experience in creating/maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.
  • Experience reviewing and approving Device Master Record (DMR) documents
  • Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.
  • Hands on Design Verification, Design Validation/Process Validation and Design History File (DHF) experience


PREFERRED QUALIFICATIONS
  • Experience supporting new product development Process, QMS or Supplier auditing experience
  • Experience with cleaning, mixing and test method validation. Experience with reagent, ELISA, HEIA manufacturing
  • Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor
  • Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP/GMPGLP/GDP requirements.


EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

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