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

Responsibilities

• Responsible for supplier quality engineering (SQE) deliverables to support Plastics category sourcing strategies and continuity of production.
• Experience in plastic injection molding. Knowledge in mold tool design, material selection, design for manufacturability (DFM), cosmetic criteria definition, and process qualification.
• Develop and monitor key performance indicators (KPIs) and other metrics.
• Develop and deploy dashboards and other visualizations required to support metrics.
• Develop risk management strategies to mitigate product and compliance risks.
• Lead SQE efforts in sustaining projects to accomplish primary objectives, including cost reduction, capacity increase, dual sourcing, and risk mitigation.
• Engage partnerships with suppliers (including sub-tiers) and supply chain management (SCM) to drive superior supplier performance and accountability.
• Experience in supplier selection, supplier production part approval process (PPAP), DOE, process capability analysis, G R&R, control plan, SPC, and inspection procedure development.
• Experience in supplier performance monitoring and improvement.
• Lead root cause analysis of supplier-related non-conforming product issues to address and resolve quality concerns via Supplier Corrective Action Report (SCAR). Drive corrective action and supplier improvement activities that directly impact performance for assigned suppliers.
• Career development and deployment of supplier quality system (QMS), process, and for-cause audits.
• Ability to set goals with a proactive approach to complete assignments in a timely, effective, and high-quality manner.
• Ability to work in a team-oriented and fast-paced environment.
• Excellent communicator for complex problems, execution plan, progress report out, and escalation to supplier quality leadership and all levels in the organization.

Required Leadership/Interpersonal Skills & Behaviors

• Demonstrates agility and responsiveness to evolving quality challenges.
• Effectively influences internal cross-functional teams and external suppliers to drive resolution and improvements.
• Demonstrates a strong customer-centric mindset. Builds strong cross-functional partnerships across Engineering, Operations, and Account Management.
• Excellent Analytical Capabilities And Problem-solving Skills.
• Communicates clearly, concisely, and persuasively across all organizational levels.
• Possess exceptional skill in handling 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.

Required Skills And Competencies

• Strong understanding of QMS systems, complaint handling, and regulatory framework (21 CFR Part 820 and Part 11 standard).
• 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.

Education and Experience

• 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.
• Master’s degree in engineering or technical or scientific discipline preferred. 3 years of progressive work experience in medical device supplier quality, quality, manufacturing, or engineering.