Quality Compliance Specialist

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

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
  
  

The Opportunity

This position works out of our Pleasanton, CA location in the Medical Device division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Quality Compliance Specialist is responsible for maintaining and managing quality systems certificates, coordinating audits, and ensuring compliance with ISO/MDSAP/MDR standards. This role involves collaboration with various stakeholders, including regulatory affairs, notified bodies, and internal teams, to ensure the effective implementation and maintenance of quality systems.

What You’ll Work On

• Maintain and update the quality systems certificates list quarterly.
• Review and collaborate on ISO/MDSAP certificates and upload them into the designated system.
• Host weekly and bi-weekly meetings with notified bodies (BSI and TUV).
• Attend strategic monthly meetings and regulatory affairs (RA) monthly meetings.
• Organize annual strategy meetings with notified bodies, including historical notes and roles review.
• Schedule yearly and additional audits with notified bodies and sites.
• Coordinate Appendix A/B/C for TUV and submit annual information forms.
• Complete and submit change notifications, collaborating with sites, RA, and notified bodies.
• Submit and evaluate change notifications and manage planned change notifications.
• Maintain key contact lists and coordinate updates with business units.
• Manage metrics for notified body performance review and audit invoice management.
• Serve as the central contact for external audits and manage audit findings in EPIQ and ABTRAQ systems.
• Track and update audit findings and share reports as needed.
• Create and classify findings, develop action plans, and ensure effective closure of audit CAPAs.
• Participate in external communities of practice and ABTRAQ improvement projects.
• Conduct touchpoint meetings for the ABTRAQ system and address audit issues.
• Support Audit Readiness activities for external audits including training staff / guidance in preparation for external audits.
• Help management with new miss program.
• Provides training in the division to increase the compliance awareness.
• Maintain audit compliance files.
• Follow up on internal and external audit observations and actions.
• Update compliance team document and procedures, as requested.
  
  

Required Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• 3 years in Quality Assurance, Quality Compliance Management or related experience
• 5 years in Medical Device/Pharma Industry
  
  

Preferred Qualifications

• Strong understanding of ISO/MDSAP standards and quality systems.
• Excellent organizational and communication skills.
• Ability to collaborate effectively with cross-functional teams.
• Experience with audit management and regulatory compliance.
• Proficiency in quality management systems (e.g., EPIQ, ABTRAQ).
• Strong analytical and problem-solving skills.
• Detail-oriented with the ability to manage multiple tasks simultaneously.
• Proficient in Microsoft Office Suite and other relevant software.
  
  

The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.