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 115,000 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.

　　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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 St. Paul, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

　　As the Senior Manager, Supplier Quality Assurance, you'll be responsible for leading the Supplier Quality department that works with engineering and suppliers to ensure that suppliers can correctly manufacture components for complex medical device products in compliance with regulatory requirements.

　　Directing all activities within the Supplier Quality Function including:

　　Quality Assurance (Supplier Quality)

　　CAPA – Supplier corrective action management; Metrics

　　NCMRs – Material Review Board and NCMR

　　Auditing – QMS, Product and Process Controls

　　Statistical Techniques; Part Qualifications

　　Provide support and guidance in preparation of responses to Internal, Division, Corporate and external audits.

　　Assure compliance with all appropriate regulatory requirements.

　　Assist in bringing new products to market in a timely manner and within regulatory requirements.

　　PRIMARY JOB SCOPE:

　　Provide strategic and functional leadership of Supplier Quality activities ensuring compliance to applicable regulatory requirements, part specifications and Quality Agreements. Manage a staff of Supplier Quality Engineers to support the supplier quality role and responsibilities. Ensure that suppliers perform and document the appropriate engineering approach for activities such as qualification and validation of processes, methods, and equipment, and assist in these efforts, as appropriate, to ensure safe, efficacious, and quality product are supplied to Abbott in accordance with regulatory and business requirements.

　　CORE JOB RESPONSIBILITIES:

　　Define and communicate overall vision and cascaded objectives for the departments.

　　Assess and manage all resource needs within the department.

　　Provide routine communications with department employees to assure awareness.

　　Assess and develop employee skillsets to assure effective support.

　　Work cross functionally in identifying and resolving technical issues.

　　Monitor supplier performance and report supplier quality trend data to upper management.

　　Lead supplier continuous improvement plans and activities.

　　Serve as a Subject Matter Expert during Internal and External inspections.

　　Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Quality Systems departments.

　　Manage Supplier Quality budget.

　　Lead the development of the Supplier Quality Engineering staff, providing growth plans and professional guidance, as appropriate.

　　Evaluate and approve the audit schedule and corresponding documentation such as audit plans/reports, extensions, corrective action documentation for findings, etc.

　　Evaluate and approve supplier requested changes or improvements. This activity may include changes such as the identification and/or approval of new supplier to provide an alternate material, site change, and manufacturing process changes.

　　Develop and consistently execute a quality strategy for suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.

　　Direct the Supplier QE team to ensure that the commitments of the Quality Agreements and Supplier History Files are being fulfilled and help facilitate resolution in cases when they are not.

　　Lead and participate on cross-functional teams to support suppliers, including active participation in Business Management Reviews as necessary.

　　Ensure timely handling of supplier exceptions with impact on product quality, safety, efficacy, and impact to the regulatory filing.

　　Lead the supplier quality team on timely and compliant handling of NCMRs and SCARs.

　　Provide a Quality Assurance service with regards to guidance on validation strategies; guidance on product, process, equipment, analytical which may or may not require a re-validation.

　　Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for Suppliers, that identify and address quality, operational, and organizational issues.

　　Promote continuous improvement, innovation, simplification aligned with Abbott and division strategy.

　　Minimum Qualifications:

　　6 to 10 years of related experience preferably in a quality/technical area or clinical laboratory

　　Bachelor’s Degree required, preferably in Electrical or Mechanical Engineering, Bioengineering or other science disciplines.

　　Demonstrated leadership experience through formal and/or informal assignments.

　　Knowledge of regulations and standards affecting IVDs, medical devices and/or biologics manufacturing (e.g., QSR, ISO, EN Quality System Requirements).

　　Up to 10% local and global travel

　　Preferred Qualifications:

　　10+ years of experience in Quality Assurance/Regulatory in a company with medically focused manufacturing environment is strongly desired.

　　6 years of experience in Supplier quality related functions.

　　4+ years of experience in management of direct resources or cross functional teams.

　　Master’s Degree preferred in MBA, MS Engineering, MS Quality, or MS Industrial Technology

　　Demonstrated experience with development, implementation, and management of quality system procedures/practices.

　　Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate, and manage projects, influence internal and external groups, and provide leadership from a quality perspective.

　　Highly developed written, oral and interpersonal skills

　　Strong statistical application experience and proficient use of various software applications such as MS Word, Excel, Access, and statistical analysis tools like Minitab.

　　Knowledge of Medical Industry Design Controls, V&V, operations, and manufacturing practices is desirable.

　　Apply Now (https://www.jobs.abbott/us/en)

　　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 (http://www.abbottbenefits.com/pages/candidate.aspx)

　　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 $125,300.00 – $250,700.00. In specific locations, the pay range may vary from the range posted.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]