Senior Supplier Quality Engineer - Medical Devices - Hudson, MA

The Senior 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 onsite at our Hudson, MA facility.

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 have pioneered innovations that drive efficiency, precision, and sustainability across industries. Their technology enables manufacturers and researchers to push the boundaries of what's possible, optimizing production processes while reducing costs and environmental impact.

Committed to continuous innovation, my client designs and delivers high-performance lasers known for their reliability and energy efficiency. Their solutions support a broad range of industries, from industrial manufacturing to healthcare, where precision and consistency are critical. As a trusted partner to global organizations, they have established a strong presence worldwide, with multiple manufacturing facilities, research centers, and service hubs.

My client fosters a culture of engineering excellence and problem-solving, empowering teams to develop cutting-edge technologies that address complex challenges. They are dedicated to shaping the future of laser applications, investing in new advancements that enhance productivity and sustainability. With a commitment to quality and long-term growth, they remain at the forefront of laser innovation, helping industries evolve through the power of light. Their Hudson, MA facility specializes in manufacturing medical device products.

Description

The Senior Supplier Quality Engineer, Medical Devices, will:

• Supplier Management & Quality Oversight - Manage supplier performance, resolve quality issues, and enforce Supplier/Distributor Quality Agreements.
• New Supplier Qualification - Lead selection, approval, and qualification of new suppliers, including first article inspections and process validations.
• Risk-Based Supplier Management - Classify and manage suppliers using a risk-based approach to ensure compliance and quality.
• Supplier Audits & Compliance - Conduct external audits, resolve findings, and ensure adherence to FDA, GMP, and EU MDR requirements.
• Issue Resolution & CAPA - Address supplier non-conformances, corrective actions, and drive continuous improvement initiatives.
• Manufacturing Support - Collaborate with engineering, R&D, and manufacturing to resolve supplier issues at incoming inspection and production.
• Supplier Change Management - Review and approve supplier change requests, ensuring smooth implementation with cross-functional teams.
• Supplier Metrics & KPIs - Track and report supplier performance through scorecards and other key performance indicators.
• Process & Yield Improvements - Drive supplier-related process improvements, defect reduction, and supply chain optimization.
• Supply Base Consolidation - Identify redundant capabilities and support supplier transfers to optimize sourcing.
• Dock-to-Stock Program - Develop and implement dock-to-stock requirements to streamline incoming material quality.
• Mentorship & Continuous Improvement - Mentor quality personnel, propose process enhancements, and strengthen supplier management practices.

Profile

• Supplier Quality - Extensive experience working with suppliers on component quality, our ideal candidate will be coming from a senior / supplier quality engineer role and title
• Medical Device - Class II medical device expertise required.
• Validation - Strong background in test method and component validation.
• Product Scope - Experience with mechanical and disposable medical products.
• Cross-Functional Collaboration - Works closely with engineering and assembly teams.
• Full Lifecycle Involvement - Managed quality from design to production.
• Compliance - Oversees incoming quality and ensures FDA compliance.
• Component Oversight - Manages quality of both internal and external components.
• Education: Bachelor's degree required.
• Local to Hudson, MA

Job Offer

• Comprehensive Health Benefits - Medical and dental coverage designed to support employee well-being.
• Retirement Savings Plans - Programs to help employees plan for their financial future.
• Performance-Based Bonuses - Incentives tied to individual and company success.
• Equity Participation - Opportunities for employees to invest in the company's growth.
• Competitive Compensation - A salary and benefits package 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.