Quality Engineer

Supplier Quality Engineer

Location: Campbell, CA

Pay: $65.00 - $78.00

3 month assignment

• Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes exist.

• Lead supplier qualification, audits, requalification, and supplier quality agreement activities.

• Own and drive Supplier Quality projects, initiatives, and continuous improvement efforts.

• Partner with Procurement, R&D, Operations, and Supply Chain to resolve supplier-related issues and prevent disruptions.

• Monitor supplier performance metrics, identify risks, and drive improvement actions.

• Manage supplier corrective action processes (SCARs), including tracking, aging metrics, and effectiveness.

• Support and/or lead supplier-related CAPAs, NCRs/NCMRs, and investigations. Docusign Envelope ID: A77B71D5-5F44-43A6-9AE8-60D5917B7538

• Conduct deep failure analysis that extends to supplier components, to find true root cause and drive corrective actions.

• Implement and manage supplier change control processes, including impact assessment and approvals.

• Lead component and supplier qualification and change projects.

PRODUCT / PROCESS QUALITY ENGINEERING

• Serve as liaison with testing laboratories for product testing, deviations, and investigations. • Perform statistical analysis of manufacturing and quality data to identify trends and improvements.

• Support validation and verification activities for product and process changes.

EDUCATION/EXPERIENCE:

• Bachelor’s degree in business engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience.

• Advanced degree and experience with catheters, endovascular/neurological devices is highly desired.

• Experience in medical devices (catheters, endovascular, or neurological) preferred.

• Experience in both product and supplier quality engineering strongly preferred.

• Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.).

• Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices.

• Excellent communications skills (both written and verbal).

• Proven ability to provide thorough and meticulous review of documents.

• Proven ability to write clear, concise, and well thought out technical documentation with focus on failure investigations and inspection procedures.

• Strong ability to perform multiple tasks concurrently with accuracy.

• Proficiency with Microsoft Office products

• May travel: 20–35% as needed to support field sales and leadership initiatives.

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.