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 Des Plaines, IL location (in office daily) 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.
They will serve as the main SQA contact during the internal and external audits and will travel up to 15% in this role locally and nationally.
What You’ll Work On
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, process, procedures and controls.
Manage the Supplier Quality Operations.
Ensure we are compliant with Applicable Regulations ISO13485 and CFR820
Assess and manage all resource needs within the department.
Manage all activities related to Supplier Quality in accordance to policy, including supplier selection and
evaluation, material qualification, inspection procedure development, supplier corrective action, supplier assessments,
supplier performance reviews and supplier development.
Define, justify, acquire and implement inspection test equipment to meet specified needs.
Re-deploy employees as priorities change to meet Division objectives.
Develop, train, implement and continuously approve upon department policies and procedures.
Ensure departmental compliance with Division SOPs and procedures.
Ensure timely and thorough review of product/process changes.
Provide timely performance & developmental evaluations of departmental staff.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
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.
Serve as SQA SME during FDA, ISO and other audits.
Strong knowledge of CFR 820, ISO 9001 and ISO 13485 regulations and standards.
Managerial experience a must.
Required Qualifications
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 timely manner.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Travel up to 15% travel.
Minimum experience 7+ years managerial experience in an FDA regulated environment including IVD and or Medical Devices.
Experience interfacing with FDA and ISO auditors a must.
ISO 13485 Certified Lead Auditor experience 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 preferred.
* 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.
