Supplier Quality Engineer

The primary responsibilities for the Supplier Quality Engineer position will be to provide leadership to the organization in the areas of Supplier Quality, Supply Chain Management, Design/Development and Operations support.

Supplier Quality Engineer Responsibilities:

• Work effectively with colleagues in cross-functional or departmental team projects.
• Work with Receiving Inspection personnel within the organization to manage Supplier issues.
• Monitor product quality levels via review of non-conforming reports, CAPAs and Customer Complaint records and drive learnings/opportunities for improvement back into the Supply Chain.
• Lead the identification and elimination of risks that could impact the achievement of first time quality.
• Perform Supplier performance reviews and maintain Supplier Scorecards.
• Plan and execute product and process related Supplier audits, drive preventative actions at the supplier's facility and minimize Supplier escapes.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks through Component Qualification and Process Validation.
• Lead Quality Improvement projects as required to support business deliverables.

Supplier Quality Engineer Qualifications & Experience:

• Bachelor's degree in Science or Engineering.
• Trained Lead Auditor, preferably to ISO 13485:2016.
• 2-4 years of Medical Device or regulated industry experience.
• Working knowledge of Quality System Regulation (QSR 21 CFR 820) and ISO 13485.
• Experienced auditing to ISO13485 and QSR 21 CFR 820 Quality standards.