Supplier QA Engineer II
Abbott Laboratories - Alameda, CA
posted 5 months ago
About the position
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. This position works out of our Alameda, CA location in the Diabetes Care division, where we focus on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We are revolutionizing the way people monitor their glucose levels with our new sensing technology. The Supplier QA Engineer II plays a crucial role in supporting the evaluation, selection, approval, and maintenance of the division's approved suppliers. This involves performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and improvement activities. In this role, you will ensure that the division's approved supplier list is maintained and accurate, assess potential new suppliers and service providers for quality and quality system capabilities through on-site or desktop audits, and communicate the division's approval requirements to suppliers while monitoring feedback per project timelines. You will also perform on-site quality assessments of new suppliers, ensuring appropriate corrective action responses to findings, and ensure that Document Control is notified of any changes to supplier statuses. Additionally, you will lead the evaluation and approval of supplier requested changes or improvements, conduct site visits at supplier sites to resolve quality issues, evaluate Exception Reports for nonconforming supplied material, and monitor supplier performance while reporting quality trend data. Your contributions will drive improvement projects to enhance supplier performance and assist in preparing area metric data for delivery to senior management.
Responsibilities
- Ensure that the division's approved supplier list is maintained and accurate.
- Assess potential new suppliers and service providers for quality and quality system capabilities through audits.
- Communicate division's approval requirements to suppliers and monitor feedback per project timelines.
- Perform on-site quality assessments of new suppliers and ensure appropriate corrective action response to findings.
- Notify Document Control of any changes to supplier statuses.
- Ensure suppliers perform and document appropriate engineering approaches to qualification and validation activities.
- Lead the evaluation and approval of supplier requested changes or improvements.
- Conduct site visits at supplier sites to resolve quality issues through process audits.
- Evaluate Exception Reports issued for nonconforming supplied material and work with suppliers on root cause investigations.
- Notify suppliers of customer complaints related to failures from supplied material and require corrective action.
- Monitor supplier performance and report supplier quality trend data.
- Drive improvement projects to enhance supplier performance.
- Assist in the preparation of area metric data for delivery to senior management.
- Recommend areas for supplier improvement as appropriate.
- Participate with Incoming Quality Control on the development of incoming inspection activities.
Requirements
- Bachelor's degree or an equivalent combination of education and work experience.
- Minimum 6 years of Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries.
Nice-to-haves
- Some working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD.
- Some knowledge in design controls, verification and validation activities, manufacturing practices, and statistical techniques.
- Some experience in conducting external quality assessments.
- Certified Lead Auditor trained.
- Proficient in MS Office (Word, Excel, Outlook).
- Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.
Benefits
- Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
- Excellent retirement savings plan with high employer contribution.
- Tuition reimbursement and the Freedom 2 Save student debt program.
- FreeU education benefit for an affordable path to getting a bachelor's degree.
