Principal Supplier Quality Engineer- Framingham, Ma

As the Senior Supplier Quality Engineer you will be ensuring suppliers deliver high-quality materials and services that meet product quality and regulatory standards. It also includes providing expertise on supplier capabilities, overseeing technical activities, and ensuring alignment with business needs.

Client Details

This company is a leading innovator in the development of advanced laser solutions for medical applications. With a focus on next-generation technologies, it is dedicated to improving lives through cutting-edge medical devices. The organization fosters a dynamic and diverse workforce, promoting a culture of collaboration and sustainability. Employees are offered challenging projects in a motivating environment, with competitive benefits to support professional and personal growth.

Description

Responsibilities:

• Participate in development projects and transfer to internal/external manufacturing facilities.
• Use a risk-based approach to classify and manage suppliers.
• Address supplier issues at incoming inspection and on the manufacturing floor.
• Resolve quality issues, including non-conformances, corrective actions, and CAPA.
• Lead the qualification and approval of new suppliers.
• Coordinate initial component quality requirements, including first article inspection and process qualification.
• Collaborate with manufacturing, engineering, R&D, and marketing on supplier capabilities.
• Conduct external supplier audits to ensure compliance and resolve quality issues.
• Enforce Supplier/Distributor Quality Agreements and maintain supplier quality records (FDA/GMP, EU MDR).
• Review and approve supplier change requests with cross-functional teams.
• Generate KPIs and supplier metrics, including quarterly scorecards.
• Identify under-performing suppliers and initiate corrective actions or transfer to alternatives.
• Consolidate the supply base and support manufacturing/service transfers as needed.
• Drive process/yield improvement projects.
• Develop and support 'dock-to-stock' program activities.
• Work independently and implement continuous improvements in supplier management.
• Mentor quality personnel and organizational partners.
• Support contract manufacturers in resolving quality issues and change requests.

Profile

Qualifications:

• 8+ years of experience in medical device or life sciences industries.
• Strong communication skills and expertise in quality tools and methodologies.
• In-depth knowledge of design control, manufacturing transfer, FDA QSR, ISO/EU MDR, process validation, CAPA, SCAR, and FMEA.
• Proficient in Microsoft Office applications.
• Certified Internal Auditor and audit experience preferred.
• ASQ or Six Sigma certification preferred.

Job Offer

Benefits:

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k) retirement plan
• Childcare support
• Paid maternity leave
• Paid paternity leave
• Tuition assistance
• Disability insurance
• Annual bonus and stock units (SRUs)
• Competitive base pay

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.