Supplier Quality Engineer

As a Supplier Quality Engineer, you will play a vital role in ensuring that suppliers adhere to the highest quality and compliance standards.

You will work in a fast-paced, collaborative environment, partnering cross-functionally with Quality, R&D, Operations, Sourcing, and Regulatory Affairs teams.

Your work will focus on supplier audits, vendor management, and supplier quality metrics, impacting the entire product lifecycle and ultimately improving patient outcomes through cutting-edge medical technology.

Key Responsibilities

Supplier Audits & Evaluations

• Conduct supplier evaluations and on-site audits to assess capabilities, determine approval status, and verify corrective actions.
• Evaluate supplier quality systems, regulatory compliance, and manufacturing processes through vendor audits.
• Collect and maintain supplier information for the Approved Supplier List (ASL).

Supplier Quality Management

• Monitor, evaluate, and report on supplier quality system performance.
• Perform component and product quality testing for supplier and component qualification.
• Use statistical engineering tools (e.g., process capability studies, SPC) to assess supplier performance.
• Identify and implement corrective and preventive actions (CAPA, SCARs, NCRs) and ensure their effectiveness.
• Work closely with suppliers to resolve quality issues, enhance processes, and drive cost-saving improvements.

Regulatory & Compliance Oversight

• Ensure supplier quality processes comply with FDA, ISO 13485, and other relevant international regulations.
• Apply Risk Management principles to supplier quality processes.
• Communicate supplier quality risks to senior management with recommended action plans.
• Required Qualifications
• Bachelor's degree in Engineering or a Scientific field.

Preferred Qualifications

• Engineering degree with experience in supplier quality engineering activities.
• Experience conducting external supplier/vendor audits.
• Expertise in root cause analysis, FMEA, Gage R&R, validation activities.
• Prior experience with Class II and Class III medical devices.
• Knowledge of medical device, pharma, or biotech industries.
• Strong proficiency in statistical quality engineering tools for supplier evaluation.
• Understanding of FDA regulations, ISO 13485, and risk management principles.
• Six Sigma Black Belt / LEAN Manufacturing experience.
• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor certification preferred.
• Exceptional communication, organization, and conflict resolution skills.

Irvine California 92614 USA

Education: Bachelors Degree