Senior Supply Quality Engineer
AbbottAbout the role
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 .
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- 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.
THIS IS AN ONSITE DAILY POSITION REQUIRED.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Our location in Westford, MA, currently has an opportunity for a Senior Supplier Quality Engineer.
WHAT YOU’LL DO
MAIN PURPOSE OF ROLE
Responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers.
Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner.
MAIN RESPONSIBILITIES
• Supplier Audits Develop and execute to a supplier audit schedule per current requirements.
• Develop audit plans and associated supplier communications.
• Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness.
• ISO lead auditor certification or equivalent is preferred.
• Qualify and then monitor supplier performance Per current requirements perform activities that will qualify new suppliers
and monitor current supplier base to ensure the status of the suppliers is correct.
• Work with suppliers as needed to ensure their performance is acceptable per site requirements.
• Work with Design and Development, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier
performance.
• CAPA Through the supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive
action activities.
• Analyze Supplier information and present supplier metrics to appropriate CAPA boards.
• Demonstrated writing and communication skills are required for this position.
• A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business
operations to achieve regulatory compliance is needed.
• Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing.
Supervisory / Management Responsibilities
(Supervision Received) Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.;
(Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.
Position Accountability / Scope
(Influence/Leadership) Cultivates a wi
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