Quality Assurance Specialist

2 days ago

Alameda, California, United States Abbott Laboratories Full time
About the Role

Abbott Laboratories is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories.

Key Responsibilities
  • Drive alignment in cross-functional meetings as a QA representative on new and on-market product design projects to ensure compliance with the design control process.
  • Review and approve engineering changes in a timely manner.
  • Collaborate with R&D and Marketing to support mobile app deployment activities for Software as a Medical Device projects.
  • Drive alignment during cross-functional review and approval of impact assessments, root-cause analysis investigation, and resolution activities.
  • Review and approve batch records for products used in design verification/validation testing and clinical investigations.
  • Ensure Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures.
  • Collect, organize, and monitor information related to quality and process improvement.
  • Participate in internal and external audits and ensure audit responses are submitted in a timely manner.
Requirements
  • Minimum 5 years of applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
  • Minimum 3 years of regulated industry experience, preferably with design control and software as a medical device.
Preferred Qualifications
  • Previous experience in completing Field Action packages or understanding of Field Action processes.
  • Familiarity with standards and regulations such as ISO 9001/13485, MDSAP, MDR/IVDR.
  • Strong and well-developed interpersonal communication skills.
  • Continuous improvement methods and application, e.g., Lean, Six Sigma.
  • Experience dealing with international locations and businesses.
About Abbott Laboratories

Abbott Laboratories 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 114,000 colleagues serve people in more than 160 countries.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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