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Quality Assurance Specialist

2 months ago

Oakland, California, United States Abbott Full time
About Abbott

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.

Job Summary

We are seeking a highly skilled Supplier QA Engineer II to join our team in Alameda, CA. As a key member of our Diabetes Care division, you will play a critical role in evaluating, selecting, and approving suppliers to ensure the highest quality products for our customers.

Key Responsibilities
  • Maintain and update the division's approved supplier list to ensure accuracy and compliance.
  • Assess potential new suppliers and service providers through on-site or desk top audits, and review of objective evidence.
  • Communicate approval requirements to suppliers and monitor feedback per project timelines.
  • Perform on-site quality assessments of new suppliers and ensure corrective action response to findings.
  • Ensure Document Control is notified of any changes to supplier statuses related to the Agile Manufacturer's Tab.
  • Lead in the evaluation and approval of supplier requested changes or improvements.
  • Conduct site visits at supplier sites to resolve quality issues and provide process audits.
  • Evaluate Exception Reports (ERs) issued for nonconforming supplied material and work with suppliers on investigation and resolution of root cause issues.
  • Notify suppliers of customer complaints related to failures resulting from supplied material and require investigation and corrective action.
  • Monitor supplier performance and report quality trend data, driving improvement projects as needed.
Requirements
  • Bachelor's degree or equivalent combination of education and work experience.
  • Minimum 6 years of Quality Assurance experience in the medical device, pharmaceutical, or other quality managed industries.
  • On-site presence at our Alameda, CA location Monday-Friday.
Preferred Qualifications
  • Working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD.
  • Knowledge in design controls, verification and validation activities, manufacturing practices, and statistical techniques.
  • Experience in conducting external quality assessments.
  • Certified Lead Auditor trained.
  • Proficient in MS Office (Word, Excel, Outlook).
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.