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.
- 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
- 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.
Vacancy expired!