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. JOB DESCRIPTION: 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. Youll 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 bachelors 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, Abbotts medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether its 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 ngersticks. 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 Youll 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. Provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System. This includes division / business support, quality/regulation expertise and consulting activities. Required Qualifications · 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. Preferred Qualifications · 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. The base pay for this position is $78,000.00 $156,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: MD Medical Devices LOCATION: United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road ADDITIONAL LOCATIONS: United States > Abbott Park : AP01, United States > Atlanta : 387 Technology Circle NW Suite 500, United States > Santa Clara : Building B - SC, United States > Sylmar : 15900 Valley View Court WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter