Supplier Quality Engineer
About The Position
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. This position works out of our Westford, MA location in the AVD Vascular division. Supplier Quality Engineer is r esponsible 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.
Requirements
- Bachelors Degree in technical/scientific area Or An equivalent combination of education and work experience
- Minimum 5 years related experience in technical or other QA related positions in a regulated industry is preferred.
- 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.
Nice To Haves
- ISO lead auditor certification or equivalent is preferred.
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.
- 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.
- Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.
Benefits
- 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 a 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
