SUPPLIER QA ENGINEER II

$83,600 - $167,200/Yr

Abbott Laboratories - Alameda, CA

Full-time - Mid Level

Alameda, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

The Supplier QA Engineer II position at Abbott focuses on ensuring the quality and compliance of suppliers within the Diabetes Care division. This role involves evaluating, selecting, and maintaining approved suppliers through quality assessments, performance monitoring, and driving corrective actions to enhance supplier quality. The engineer will work closely with suppliers to ensure adherence to quality standards and will play a key role in improving supplier performance to support the division's mission of providing life-changing products for diabetes management.

Responsibilities

• 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 audits.
• Communicates division's approval requirements to suppliers and monitors feedback per project timelines.
• Performs on-site quality assessments of new suppliers and ensures corrective action responses to findings.
• Ensures Document Control is notified of any changes to supplier statuses.
• Leads in the evaluation and approval of supplier requested changes or improvements.
• Conducts site visits at supplier sites to resolve quality issues through process audits.
• Evaluates Exception Reports (ERs) for nonconforming supplied material and works with suppliers on root cause investigations.
• Notifies suppliers of customer complaints related to failures from supplied material and requires corrective action.
• Monitors supplier performance and reports quality trend data, driving improvement projects as needed.
• Assists in preparing area metric data for delivery to Sr. Management and recommends areas for supplier improvement.
• Participates with Incoming Quality Control on developing incoming inspection activities or reducing these activities through the Material Certification Program.
• Responsible for approving First Article Inspections and/or Golden Samples initiated by suppliers.

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 communications with 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 Freedom 2 Save student debt program.
• FreeU education benefit for affordable bachelor's degree paths.