Abbott Senior Quality Engineer in California
DO WORK THAT MATTERS
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Sr Quality Engineer is within our Toxicology Business Unit located in Pomona , CA . 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.
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.
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.
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.
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please send an email to MyRecruiter@alere.com.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org