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Senior Quality Engineer

Company: Gateway Recruiting - Executive Recruiters
Location: Pomona
Posted on: February 19, 2021

Job Description:

In this role, you will report to the Site Head of Quality and actively lead QA support for the product development process and design transfer to manufacturing, ensuring product and process conformance to FDA Design Controls, ISO 13485:2016, ISO 14971:2012 and other applicable regulatory and technical standards.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.* Other duties as assigned. BASIC QUALIFICATIONS:Education and Experience Requirements:* BS/BA in field of Science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering, OR equivalent experience.* Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.* Minimum of 7 years of Quality Assurance engineering experience (design controls, change control, process validation, on market quality engineering support and risk management) * Minimum of 7 years hands on CAPA System, Non-conformity System, Root Cause investigation and manufacturing process improvement experience.* Minimum of 5 years 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 required.* Hands on Design Verification, Design Validation/Process Validation and Design History File (DHF) experience required.* Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP/GMPGLP/GDP requirements.Preferred Qualification:* Experience supporting new product development desired.* Process, QMS or Supplier auditing experience desired.* Experience with cleaning, mixing and test method validation required.* Experience with reagent, ELISA, HEIA manufacturing desired.* Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.Powered by JazzHRYZSyAD6cR2

Keywords: Gateway Recruiting - Executive Recruiters, Pomona , Senior Quality Engineer, Engineering , Pomona, California

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