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. We have an exciting opportunity for aSr Quality Engineerlocated atSan Diego, 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.
Other duties as assigned.
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 3-4 years or more of Quality Assurance engineering experience (design controls, change control, process validation, on market quality engineering support and risk management)
Minimum of 3-4 years or more hands on CAPA System, Non-conformity System, Root Cause investigation and manufacturing process improvement experience.
Minimum of 2 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
Industry experience inAreospace, Regulated Manufacturing, Medical Device, Biotech, Pharma, OR Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP/GMPGLP/GDP requirements.
Firmware or Software Validation
Non Product Assessments
Hands on Design Verification, Design Validation/Process Validation and Design History File (DHF) experience required.
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.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to **********.
#LI-KE1JobQualityOrganizationGeneral & AdministrativeScheduleFull-time
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