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Quality Assurance Specialist

2 months ago

Alameda, California, United States Abbott Laboratories company Full time

About Abbott Laboratories

Abbott Laboratories is a leading global healthcare company that provides innovative solutions to help people live more fully at all stages of life. Our diverse 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 Mission

At Abbott Laboratories, we are committed to delivering high-quality products and services that meet the evolving needs of our customers and patients. We strive to create a work environment that fosters collaboration, innovation, and growth, where our employees can thrive and make a meaningful impact.

The Opportunity

We are seeking a highly skilled Quality Assurance Specialist to join our team in the Diabetes Care division. As a Quality Assurance Specialist, you will play a critical role in ensuring compliance with regulatory requirements and industry standards, including FDA, ISO, MDD, CDR, and Japan regulations.

Key Responsibilities

  • Lead and support internal quality audits to assess compliance with regulatory requirements and industry standards.
  • Participate in and support external regulatory audits, ensuring timely closure of audit cycles.
  • Support Audit Readiness activities, including training staff and providing guidance in preparation for external audits.
  • Identify and manage compliance risks, developing strategies to address gaps and ensure regulatory compliance.
  • Assist in the management of near-miss programs, tracking and analyzing incidents to prevent future occurrences.
  • Monitor and track regulations and industry standards revisions, evaluating and communicating the impact on our business.
  • Prepare and review metrics data to ensure compliance and identify areas for improvement.
  • Promote awareness and understanding of quality and compliance within the division, providing training and guidance to increase compliance awareness.
  • Participate in compliance initiatives and other assigned projects.

Requirements

  • AS or BS degree or combination of appropriate education and experience.
  • 5 years of experience in the medical device industry, with 5 years auditing per ISO and/or FDA standards.
  • Excellent writing skills and ability to communicate effectively at multiple levels within the organization.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Strong organizational and follow-up skills, with attention to detail.
  • Ability to travel, including internationally.

Preferred Qualifications

  • Lead Auditor Certification for ISO 13485 or 9001:2000.