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: 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. The Opportunity This position works out of our Lillehei location in the St. Paul, MN location. In this role, you will ensure that processes and staffing are appropriately developed and implemented to maintain the quality system, participate in establishing strategic vision/goals in alignment with site organization and division, ensure compliance within organization to all applicable internal requirements and external regulations, and establishes/maintains quality system. The responsibilities will also include facilitating internal inspections, as well as inspections with outside regulatory agencies. What You’ll Work On Ensure that company products maintain compliance with US and foreign regulation and declared standards and provides constructive evaluation of test protocols and reports to conclude and provide evidence of conformity. Assure that activities are performed and documented per our systems and procedures in accordance with Abbott policies and applicable quality and regulatory requirements intended to assure the effectiveness and safety of our products. Makes decisions regarding work processes or operational plans and schedules in order to achieve compliance objectives for the division Analyze global regulations and applicable standards and drive creation of formal External Requirements Plans in support of Research and Development. Lead cross functional teams of SMEs to complete detailed assessment of new or revised regulations and applicable standards. Initiate appropriate changes to External Requirements Plans for all company product families and coordinate with SMEs when additional testing or data is necessary to support Declarations of Conformity. Coordinate with Regulatory Affairs on maintaining current Declarations of Conformity in sync with External Requirements Plans. Maintains/consolidates the various certifications divisionally (QMS and Design) Conduct CAPA investigation and able to judge the quality of investigations based on technical knowledge, tracks issues through to closure including reviewing the corrective action taken. Monitors compliance of company policies and procedures with regulatory requirements (e.g. compliance with FDA, EMEA, CALA and APAC and emerging market regulations and standards etc). Required Qualifications Bachelor’s Degree in Engineering, Sciences, or related discipline 5-8 years of related work experience in a similar role within a regulated industry (i.e. medical device, Pharmaceutical, Aerospace, etc), including quality management system (QMS) experience, and/or experience with regulatory audits and certification management Demonstrated knowledge of compliance with FDA, EMEA, CALA and APAC, and emerging market regulations and standards etc. Demonstrated experience building strategic partnerships to further departmental and organizational objectives Proficient with MS Office (Word, Excel, Outlook) Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Preferred Qualifications Advanced degree in Engineering, Sciences, or related discipline Medical device experience Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization 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 and @AbbottGlobal. 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. JOB FAMILY: Operations Quality DIVISION: SH Structural Heart LOCATION: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing 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 it’s 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 life’s 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