Principal Supplier Quality Engineer - Med Device - Southborough

The Principal Supplier Quality Engineer will lead supplier qualification, compliance, and performance management to ensure high-quality components meet regulatory and manufacturing requirements for medical devices. They will drive supplier audits, issue resolution, and process improvements while collaborating with cross-functional teams to optimize supply chain quality and efficiency.

Client Details

My client is a global leader in laser technology, specializing in advanced laser solutions for materials processing, medical applications, and scientific research. With decades of expertise, they drive efficiency, precision, and sustainability across industries, enabling manufacturers and researchers to optimize production while reducing costs and environmental impact. Known for reliable, energy-efficient lasers, their solutions span industrial manufacturing and healthcare. Committed to innovation and engineering excellence, they empower teams to solve complex challenges and invest in advancements that enhance productivity and sustainability, maintaining a strong global presence and shaping the future of laser applications.

Description

• Manage supplier performance, resolve quality issues, and enforce Supplier/Distributor Quality Agreements.
• Lead the selection, approval, and qualification of new suppliers, including first article inspections and process validations.
• Classify and manage suppliers using a risk-based approach to ensure compliance and quality.
• Conduct external audits, resolve findings, and ensure adherence to FDA, GMP, and EU MDR requirements.
• Address supplier non-conformances, corrective actions, and drive continuous improvement initiatives.
• Collaborate with engineering, R&D, and manufacturing to resolve supplier issues during incoming inspection and production.
• Review and approve supplier change requests, ensuring smooth implementation with cross-functional teams.
• Track and report supplier performance through scorecards and other key performance indicators.
• Drive supplier-related process improvements, defect reduction, and supply chain optimization.
• Identify redundant capabilities and support supplier transfers to optimize sourcing.
• Develop and implement dock-to-stock requirements to streamline incoming material quality.
• Mentor quality personnel, propose process enhancements, and strengthen supplier management practices.

Profile

• Extensive experience in supplier quality, ideally from a senior or supplier quality engineer role.
• Expertise in Class II medical devices.
• Strong background in test method and component validation.
• Experience with mechanical and disposable medical products.
• Collaborates closely with engineering and assembly teams.
• Involved in quality management from design through production.
• Ensures compliance with FDA regulations and oversees incoming quality.
• Manages quality control for both internal and external components.
• Bachelor's degree required.

Job Offer

• Comprehensive medical and dental coverage to support overall well-being.
• Retirement savings plans to help employees secure their financial future.
• Performance incentives tied to individual and company achievements.
• Opportunities for equity participation, allowing employees to share in company growth.
• Competitive salary and benefits designed to attract and retain top talent.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.