Supplier Quality Specialist at Abbott Pediatrics

Princeton, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jul, 26

Salary

156000.0

Posted On

05 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality assurance, Supplier quality, Auditing, Regulatory compliance, FDA, QSR, ISO, Design controls, Verification and validation, Manufacturing practices, Statistical techniques, Root cause analysis, Corrective action, Document control, Quality system assessments

Industry

Hospitals and Health Care

Description

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 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 The Supplier Quality Specialist works out of our Princeton, NJ location in the Abbott Point of Care Diagnostics business. Our Point of Care Diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. This role supports the selection, approval and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities. What You’ll Work On Ensures that the division’s approved supplier list is maintained and accurate. Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desk top audits, and review of other objective evidence, as required. Communicates division’s approval requirements to supplier and monitors feedback per project timelines. Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings. Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab. Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate. Leads in the evaluation and approval of supplier requested changes or improvements. This activity may also include the identification and/or approval of a new supplier to provide an alternate material. Conducts site visits at supplier sites to bring back understanding on how to resolve quality issues (process audits). Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues. Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action. Monitors supplier performance and reports supplier quality trend data. Drives improvement projects, as required, to improve supplier performance. Assists in the preparation of area metric data for delivery to Sr. Management. Recommends areas for supplier improvement, as appropriate. Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program. Education and Experience Bachelor’s Degree OR equivalent combination of education and work experience. Degree in Engineering or STEM related field preferred. Minimum of 6 years of Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries. Working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD. Knowledge in the areas of design controls, verification and validation activities, manufacturing practices and statistical techniques. Experience in conducting external quality assessments. Certified Lead Auditor trained. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers. The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

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Responsibilities

The Supplier Quality Specialist manages the approved supplier list and conducts quality system assessments to ensure compliance with regulatory standards. They also monitor supplier performance, drive corrective actions, and lead improvement projects to maintain high quality standards for supplied materials.