Director Quality Assurance

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 Pomona location in the Cardiometabolics division. As the Director, Quality Operations, you will develop, establish and maintain operational quality assurance programs, policies, processes, procedures and controls ensuring that the organization conforms to established standards and agency regulations. What You'll Work On Acts as Site Management Representative with overall site responsibility to establish an effective and compliant Quality System that meets changing regulatory requirements and business needs. Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies. Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems. Supports operations in continuous improvement initiatives by providing direction on process validation/verification requirements for proposed changes. Provide overall functional Quality leadership which may include: Supplier Quality Assurance and Operations Quality. Support New Product Initiatives as a Core Team Member supporting design control and design transfer projects. Assures Quality provides technical support and services to Operations and Research & Development functions. Supporting approved projects and objectives of both functions. Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. Be a champion of Quality, Lean and disciplined problem solving throughout the organization to identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility. Demonstrates effective change leadership by building strategic partnerships across functional areas, business units and geographies to further departmental and organizational objectives. Support all Divisional initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), 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. Communicates strategic direction, quality policies/procedures and effectiveness of the Quality system to the organization. Directs and controls the activities and budget of site QA functional operations. Required Qualifications Bachelor's Degree in Life Sciences or Engineering. Minimum of 10 years of related work experience in IVD, Medical Devices/Pharma/Biotech organization with at least 5 years in a Quality Assurance/Operations/R&D site leadership role. At least 3+ years management with demonstrated compliance excellence, value improvement, risk reduction, and cost containment. Strong leadership skills with demonstrated ability to create momentum and deliver excellent results. Strong organization, speaking skills, and influential management ability. Ability to work in a highly matrixed and geographically diverse business environment. Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Preferred Qualifications Master's Degree or MBA. Class III or II medical device background. Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies. Ability to travel approximately 25%, including internationally. Conducting root cause analysis on highly technical problems and solving problems that impact work processes and personnel in multiple units or departments. 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: 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 , on /Abbott and on Twitter @AbbottNews. Divisional Information Diagnostics We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people. Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level. Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges. The base pay for this position is $164,900.00 - $329,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: CMI ARDx Cardiometabolic and Informatics LOCATION: United States > Pomona : 821 Towne Center Drive ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: Not Applicable 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: EEO is the Law link - Espanol:

Created: 2024-11-05