Supplier QA Engineer II

The Opportunity

This position works out of our Alameda, CA location in the Diabetes Care division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.

We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Supplier QA Engineer II supports in the evaluation, 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.

Responsible for approving First Article Inspections and / or Golden Samples, as initiated by suppliers.

Required Qualifications

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

Preferred Qualifications

Some working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD

Some knowledge in the areas of 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 communications with ability to effectively communicate at multiple levels in the organization