Sr Quality Compliance Specialist

Abbott Laboratories • Alameda, CA

36d • Onsite

About The Position

We are seeking a detail-oriented and proactive Sr. Quality Compliance Specialist to join our Compliance team. This role is critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP. The Compliance Specialist will lead and support internal and external audits readiness activities, manage audit-related documentation, and drive quality system improvements. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

Requirements

• Bachelor’s degree in a scientific, engineering, or quality-related field.
• 5+ years of experience in quality assurance or regulatory compliance in the medical device industry.
• Strong knowledge of ISO 13485, MDSAP, and other applicable regulations.

Nice To Haves

• Experience supporting or leading audits (internal and external).
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced environment

Responsibilities

• Maintain and continuously improve the inspection readiness program to ensure the site is always prepared for regulatory and internal audits.
• Coordinate and support internal audits, including planning, execution, reporting, and follow-up on corrective actions.
• Serve as a support during external audits (e.g., Notified Bodies, FDA, Corporate), including logistics, documentation, and auditee coaching.
• Monitor and ensure compliance with applicable regulatory standards applicable to ADC (ISO 13485, MDSAP, 21 CFR Part 820, etc.).
• Maintain audit schedules, records, and metrics; track and trend audit findings to identify systemic issues.
• Collaborate with cross-functional teams to ensure timely and effective CAPA implementation related to audit findings.
• Support the development and delivery of training on audit readiness and compliance topics.
• Participate in quality system improvement initiatives and support regulatory submissions as needed.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees