Supplier Quality Assurance Manager

4 weeks ago

Des Plaines, Illinois, United States Abbott Full time
About Abbott

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, providing innovative solutions to improve health outcomes and enhance quality of life.

The Opportunity

This position works out of our Des Plaines, IL location in the Abbott Molecular Diagnostics, Quality Assurance Group. Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

The person hired in this role will manage the Supplier Quality Assurance Team, serving as the main SQA contact during internal and external audits and traveling up to 15% locally and nationally.

Key Responsibilities
  1. Manage the development and administration of departmental activities of Supplier Assurance while maintaining compliance to, and driving continuous improvement of, related quality assurance programs, policies, processes, and controls.
  2. Ensure compliance with Applicable Regulations ISO13485 and CFR820.
  3. Assess and manage all resource needs within the department.
  4. Manage all activities related to Supplier Quality in accordance with policy, including supplier selection and evaluation, material qualification, inspection procedure development, supplier corrective action, supplier assessments, supplier performance reviews, and supplier development.
  5. Define, justify, acquire, and implement inspection test equipment to meet specified needs.
  6. Re-deploy employees as priorities change to meet Division objectives.
  7. Develop, train, implement, and continuously approve upon department policies and procedures.
  8. Ensure departmental compliance with Division SOPs and procedures.
  9. Ensure timely and thorough review of product/process changes.
  10. Provide timely performance and developmental evaluations of departmental staff.
  11. Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback.
  12. Maintain a safe and professional work environment.
  13. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  14. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  15. Serve as SQA SME during FDA, ISO, and other audits.
Requirements
  • Strong knowledge of CFR 820, ISO 9001, and ISO 13485 regulations and standards.
  • Managerial experience is a must.
  • Bachelor's Degree or related field or an equivalent combination of education and work experience.
  • Minimum 5 years related to supplied product quality within an FDA/ISO certified environment.
  • Multi-tasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Travel up to 15%.
  • Minimum experience 7+ years managerial experience in an FDA regulated environment including IVD and/or Medical Devices.
  • Experience interfacing with FDA and ISO auditors is a must.
  • ISO 13485 Certified Lead Auditor experience is required.
  • Responsibility includes implementing and maintaining Supplier Control metrics. Prepare and present metrics in management review meetings.
  • Experience in Purchasing Controls/Supplier Quality.
Preferred Qualifications
  • Strong leadership skills to motivate and enable department employees in meeting objectives.
  • Experience in departmental budgeting and supervision/training/managing staff.
  • At least 5 years of experience in Purchasing Controls/Supplier Quality.
  • Experience with computers and software application knowledge consistent with engineering environments.
  • Experience working in a broader enterprise/cross division business unit model.
About 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.

Abbott is 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.

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