Sr. Supplier Quality Engineer - Metals (Onsite - Acton, MA)

This role focuses on managing and improving supplier quality for metal components used in medical devices. The Supplier Quality Engineer works closely with suppliers and internal teams to ensure products meet quality and regulatory requirements, drive supplier performance improvements, investigate and resolve quality issues, and support sourcing and manufacturing initiatives.

About the role

The Supplier Quality Engineer ensures supplier governance and related quality systems, creating, monitoring, and reporting on metrics that reflect the health and capability of the supplier quality system. The role involves maintaining records and databases, ensuring products and new projects meet quality and regulatory requirements, and interfacing with internal departments (e.g., Manufacturing Operations, Design Engineering, Procurement, Regulatory Affairs) as well as external suppliers and contractors. Effective communication of supplier quality performance metrics, status, and requirements is critical. The role also involves collaborating on supplier selection, improving supplier performance, and positively impacting product quality globally.

This position is based in Acton, MA, and includes approximately 25% travel.

Responsibilities

• Manage supplier quality engineering (SQE) deliverables to support metals category sourcing strategies and production continuity, with experience in metal stampings and spring forming.
• Knowledge in material selection, design for manufacturability (DFM), cosmetic criteria definition, and process qualification.
• Develop and monitor key performance indicators (KPIs) and other metrics, including dashboards and visualizations.
• Develop risk management strategies to mitigate product and compliance risks.
• Lead SQE efforts in sustaining projects for cost reduction, capacity increase, dual sourcing, and risk mitigation.
• Engage with suppliers (including sub-tiers) and supply chain management (SCM) to drive superior supplier performance and accountability.
• Experience in supplier selection, Production Part Approval Process (PPAP), DOE, process capability analysis, G R&R, control plans, SPC, and inspection procedure development.
• Monitor and improve supplier performance.
• Lead root cause analysis of supplier-related non-conforming product issues and resolve quality concerns via Supplier Corrective Action Reports (SCAR).
• Drive corrective action and supplier improvement activities.
• Coordinate review, technical assessment, and documentation for supplier change requests.
• Conduct supplier quality system (QMS), process, and for-cause audits.
• Set goals with a proactive approach to complete assignments in a timely, effective, and high-quality manner.
• Work in a team-oriented, fast-paced environment.
• Communicate complex problems, execution plans, progress reports, and escalations to leadership and all organizational levels.

Requirements

• Demonstrates agility and responsiveness to evolving quality challenges.
• Effectively influences internal cross-functional teams and external suppliers to drive resolution and improvements.
• Strong customer-centric mindset with the ability to build cross-functional partnerships.
• Excellent analytical capabilities and problem-solving skills.
• Communicates clearly, concisely, and persuasively across all organizational levels.
• Handles competing priorities and requirements, especially with external entities.
• Adept at driving consensus and action, culminating in clear communication.
• Ability to work in a team-oriented, high-energy, and fast-paced environment.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related field.
• 5-8 years of progressive work experience in medical device supplier quality, quality, manufacturing, or engineering (for candidates with a bachelor’s degree).
• 3 years of progressive work experience in medical device supplier quality, quality, manufacturing, or engineering (for candidates with a master’s degree).
• Experience with metals manufacturing or materials is a strong plus.

Skills

• Strong understanding of QMS systems, complaint handling, and regulatory framework (21 CFR Part 820 and Part 11).
• Exceptional organizational skills and attention to detail.
• Excellent written and verbal communication abilities.
• Professional handling of confidential and sensitive information.
• Proficiency in analyzing quality data and generating actionable insights through dashboards or reports.

Benefits

• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid time off (PTO).
• Additional employee wellness programs.

Pay

Annual base salary range for this role is $87,100.00 - $130,600.00. This position may also be eligible for incentive compensation.

Schedule

This is an on-site position based in Acton, MA, with approximately 25% travel, depending on business needs.