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 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. 

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 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, Pleasanton, CA or Minnetonka, MN currently has an on-site opportunity for a Staff Auditor, Quality Systems professional.  This new team member will be a leader and mentor responsible for implementing internal audits required for compliance with global regulatory standards and collaborating with Abbott Medical Device Business Units for external inspection preparation and support. 

What You’ll Work On 

Internal audit planning, developing audit schedules and plans, performing and documenting audits and managing related following up activities including related KPI and metrics reporting.  

Support the development, training, and supervision of auditors to improve their ability to provide inspection readiness support.  

Lead and mentor staff, influence colleagues and peers, and continually strive to improve the audit and inspection readiness programs. 

·                Bachelors Degree (± 16 years), Related field OR an equivalent combination of education and work experience, 

·                Masters Degree (± 18 years) Preferred 

·                Minimum 6 years, Related work experience with a strong understanding of specified functional area. 

·                Solid understanding and application of business concepts, procedures and practices. 

·                Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. 

·                Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. 

·                Has a sound knowledge of a variety of alternatives and their impact on their business unit. 

·                Prior experience in the medical device industry and/or quality systems. 

·                Strong working knowledge of regulations and standards applicable to medical devices, including FDA Code of Federal Regulations, cGMP, ISO14971, EUMDR, among others. 

·                Proven track record of managing projects from initiation to completion in a timely manner.  

·                Strong technical writing skills and excellent oral and written communication skills. 

·                Demonstrated leadership/management skills with respect to achievement of company goals and objectives.  

·                Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.   

·                Experience working in a broader enterprise/cross-division business unit model. Ability to work in a highly matrixed and geographically diverse business environment. 

·                Prior audit and management experience, preferably in Medical Devices. 

·                Prior experience in the preparation and management of external inspections, preferably with FDA. 

·                Anticipate 25-50% travel and may have to travel with short notice to perform or support audits.