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: Participate in career development activities and training opportunities to enhance skills and knowledge.
• Coordinate review, technical assessment, and documentation for supplier change requests.
• Experience with 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, high energy, and fast-paced environment.

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.

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 for those with a bachelors degree.

Additional Information

• This position is based at our Acton, MA site. Estimated travel: ~25%, with flexibility based on business needs.
• Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $87,300.00 - $130,950.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: Medical, dental, and vision insurance 401(k) with company match Paid time off (PTO) And additional employee wellness programs.
• Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.