Staff Auditor, Quality Systems- Medical Devices

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals and branded generic medicines. Over 114 000 colleagues serve people in more than 160 countries.

• Career development within an international company.
• Free medical coverage in the Health Investment Plan (HIP) PPO plan.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, Freedom 2 Save student debt program and FreeU education benefit.
• A company recognized as a great place to work, earning best-place awards.
• Commitment to diversity, working mothers, female executives, and scientists.

Location:

Sylmar, CA;
Pleasanton, CA; or Minnetonka, MN. Position:
Staff Auditor, Quality Systems
. Required to conduct internal audits and support external inspection preparation.

• Internal audit planning, development of audit schedules and plans.
• Performing and documenting audits; managing follow‑up activities including KPI and metrics reporting.
• Supporting development, training and supervision of auditors to improve inspection readiness.
• Leading and mentoring staff, influencing peers, and continually improving audit and inspection readiness programs.
• Providing leadership, oversight, and project management for external inspections related to our quality system.

• Bachelor’s degree in a related field (±16 years) or an equivalent combination of education and work experience.
• Master’s degree (±18 years) preferred.
• Minimum 6 years of related work experience with a strong understanding of the specified functional area.
• Solid understanding and application of business concepts, procedures and practices.
• Experience performing in a quality system environment; failure to comply could result in regulatory non‑compliance.
• Ability to analyze data, evaluate multiple factors, and exercise judgment within defined policies.
• Sound knowledge of alternatives and their impact on the business unit.

• Prior experience in the medical device industry and/or quality systems.
• Strong working knowledge of relevant regulations and standards (FDA CFR, cGMP, ISO 14971, EUMDR, etc.).
• Proven track record of managing projects from initiation to completion.
• Strong technical writing skills and excellent oral and written communication.
• Demonstrated leadership/management skills aligning with company goals and objectives.
• Ability to create positive relationships and provide constructive feedback.
• Experience working in a broader enterprise/cross‑division business unit model within a matrixed environment.
• Prior audit and management experience, preferably in medical devices.
• Prior experience preparing and managing external inspections, preferably with FDA.
• Anticipated 25–50 % travel, including short‑notice travel for audits.

Job base pay: $78,000.00 – $ (may vary by location).

• Job family:
  Operations Quality.
• Division: MD Medical Devices.
• Primary location:
  Minnetonka, MN (14900 Minnetonka Industrial Road).
• Additional locations include:
  Abbott Park (AP01);
  Atlanta (387 Technology Circle NW Suite 500);
  Santa Clara (Building B – SC);
  Sylmar (15900 Valley View Court).
• Work shift:
  
  Standard.
• Travel:
  Yes, 50 % of the time.
• Medical surveillance:
  No.
• Significant work activities:
  Continuous sitting >2 hrs per 8‑hr day, keyboard usage ≥50 % of workday.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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