Senior Quality Compliance Specialist (on-site) at Abbott Laboratories

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 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.
• 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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies 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 Opportunity

Our location in Sylmar, CA or Minnetonka, MN currently has an on-site opportunity for a Senior Quality Compliance Specialist.  This new team member will support external and internal audit processes and activities.  

What You’ll Work On

• Plan, perform, support and document QMS compliance audits as certified lead auditor or team member. These audits must be tracked to standards and regulations.
• Manage the tracking of the Audit CAPA corrective actions.  Complete Audit CAPA investigations as owner.
• Develop and maintain internal audit checklists and tools.
• Support internal and external team Sharepoint sites.
• Maintain internal audit compliance files.
• Follow up on internal and external audit observations and actions.
• Update compliance team documents and procedures, as requested.
• Support divisional quality and compliance initiatives, goals, and metrics.
• Assist and support customer and external audits, as requested.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform specialty audits, as requested by management.
• Mentor compliance and quality team members.
• Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

• Bachelor’s Degree OR an equivalent combination of education or work experience.  
• Minimum 3 years Quality Assurance, Internal Auditing, Quality Compliance Management or related experience
• Minimum 5 years Medical Device/Pharma/regulated industry experience

Preferred Qualifications

• Extensive experience on performing internal audits, managing external inspections/responses and be proficient in CAPA processes.
• Experience working in a broader enterprise/cross-division business unit model.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 15-20%, including internationally.
• Any professional Quality System related certification (i.e. ASQ Quality Auditor, ASQ Quality Engineer, ASQ Biomedical Auditor, or equivalent).

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.