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: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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 Plymouth, MN location in the Electrophysiology (EP) business In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. [insert division name. [Insert division description]. WHAT YOU’LL DO We are recruiting for a Director, Quality Engineering located in Plymouth, MN. As Director, Quality Engineering, this role will be responsible to foster a culture of cross functional alignment and compliant problem solving. This role is responsible for developing strategies that result in robust and streamlined Production and Process Controls while partnering with the development team to incorporate improvements into future product designs. You will be responsible for ensuring Abbott provides world-class devices conforming to established requirements and specifications, built following validated processes to meet our customer needs. The Director, Quality Engineering is the site-level Quality Management representative, who will champion the manufacturing quality system requirements and ensure they are effectively established and maintained as well as reports on the performance of the quality system to management with executive responsibility. Job Duties: Provides overall leadership for Quality policies, approaches, design controls, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems. Oversee the development, implementation, improvement and monitoring of quality processes and procedures to ensure that a device conforms to its specifications Identify and implement strategies for more effective/efficient P&PC in the future Serves as the primary site Management Representative for external regulatory inspections and audits. Be an effective member of the cross-functional Director organization to foster a culture of continuous quality compliance, cost, and predictive measures improvements. EDUCATION AND EXPERIENCE YOU’LL BRING Required Bachelor’s degree in Engineering or equivalent Minimum 10 years of progressive work experience in medical device or high technology industries. Minimum 5 years prior management experience. Demonstrated ability to understand/ familiarity with applicable FDA and TUV regulations, and other relevant clinical/regulatory requirements. Class III or II medical device background in a Quality Leadership role. Quality System Regulations knowledge (ISO 9001, ISO 13485). Demonstrated ability to create relationships, influence and move critical projects forward in alignment with key stakeholders. Experience working in a regulated environment required: GMPs, GLP's and GCP's. Proven project management skills; analytical and highly developed problem solving skills. Strong interpersonal skills. Strong leadership skills with demonstrated ability to create momentum and deliver excellent results highly desired. Strong written and oral communication and negotiations skills. Highly developed problem-solving skills. Top performer in managing multiple tasks and priorities. Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies. Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. Ability to travel, including internationally. WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 $143,300.00 – $286,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: EP Electrophysiology LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: 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