Save Job Back to Search Job Description Summary Similar JobsComprehensive healthcare, strong 401(k), performance bonusesStock Options, join a leader in medical device manufacturing!About Our ClientMy client is a global leader in advanced laser technology, providing cutting-edge solutions for a wide range of industries, including manufacturing, medical, and scientific applications. With decades of expertise, they design and produce high-performance laser systems that drive efficiency, precision, and sustainability across critical sectors. Their technology is known for its energy efficiency and reliability, helping businesses reduce operational costs while enhancing productivity.Their portfolio spans from individual laser diodes to fully integrated laser systems, beam delivery solutions, and real-time quality assurance technologies. Their products are designed for seamless integration, offering configurable options to meet diverse application requirements. These solutions support industries such as automotive, aerospace, biomedical, and telecommunications, enabling advancements in materials processing, microfabrication, and high-precision machining.With a strong commitment to continuous innovation, my client has built a global presence, operating manufacturing facilities, research labs, and service centers across multiple regions. Their focus on sustainability and efficiency has positioned them as a trusted partner for companies seeking to optimize performance while minimizing environmental impact. Guided by an experienced leadership team, they continue to pioneer advancements in laser technology, shaping the future of industrial and scientific applications.Job DescriptionThe Senior Supplier Quality Engineer (Medical Devices) will:Supplier Management - Classify, qualify, and oversee suppliers using a risk-based approach.Issue Resolution - Manage supplier non-conformances, corrective actions, and CAPAs.Supplier Qualification - Lead supplier selection, approval, and process validation activities.Component Quality Oversight - Define and coordinate initial component quality requirements, including first article inspection and process qualification.Cross-Functional Collaboration - Partner with engineering, R&D, manufacturing, and marketing to assess supplier capabilities and support product development.Supplier Audits & Compliance - Conduct external supplier audits to ensure FDA/GMP and EU MDR compliance, driving corrective actions as needed.Supplier Change Management - Evaluate and approve supplier change requests, ensuring seamless implementation.Supplier Performance Metrics - Develop KPIs, generate scorecards, and monitor supplier performance for continuous improvement.Process Improvement - Identify underperforming suppliers, drive defect reduction, and support supply base consolidation.Manufacturing Support - Address supplier-related quality issues at incoming inspection and on the manufacturing floor.Contract Manufacturer Support - Resolve quality issues and manage change requests with contract manufacturers.Continuous Improvement - Propose and implement enhancements to supplier management programs while mentoring quality personnel.Be onsite at our Hudson, MA facilityMPI 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.The Successful ApplicantSupplier Quality Expertise - Experience in a supplier-facing role, ensuring component quality and compliance. Our ideal candidate is coming from a Senior Supplier Quality Engineer title.Medical Device Background - Must have Class II medical device experience.Validation Experience - Proficient in test method validation and component qualification.Mechanical & Disposable Products - Experience with medical devices involving mechanical and disposable components.Regulatory & Compliance - Knowledge of FDA requirements and quality oversight for incoming materials.Lifecycle Involvement - Managed quality from concept through full-scale manufacturing.Cross-Functional Collaboration - Works closely with engineering, assembly, and manufacturing teams.Component Quality Oversight - Ensures quality standards for both internal and external components.Problem-Solving - Identifies and resolves supplier-related quality issues.Process Improvement - Drives quality improvements and risk mitigation strategies.Documentation & Audits - Experience with supplier audits, CAPAs, and quality documentation.Education - Bachelor's degree required.Local to Hudson, MAWhat's on OfferComprehensive Health Coverage - Multiple medical and dental plan options to suit individual needs.Retirement Savings - Competitive 401(k) plan with immediate vesting and diverse investment options.Performance-Based Bonuses - Incentives tied to individual and company success.Employee Stock Purchase Plan - Opportunity to invest in the company at a favorable rate.Paid Time Off - Generous vacation policy with rollover options.Professional Growth - Support for career development through mentorship and training.Work-Life Balance - Policies designed to support personal and professional well-being.ContactIsabel ReynesQuote job refJN-022025-6668184Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationHudsonContract TypePermanentConsultant nameIsabel ReynesJob ReferenceJN-022025-6668184
