Supplier Quality Engineer, Plastics (Onsite - Acton, MA)

Insulet Corporation•Acton, MA

3d•$70,400 - $105,650•Onsite

About The Position

Insulet is seeking a highly motivated and performance-driven Supplier Quality Engineer specializing in Plastics to join their Center of Excellence. This role is crucial for ensuring supplier governance and the effectiveness of related quality systems, particularly for medical devices. The Engineer will be responsible for creating, monitoring, and reporting on supplier quality metrics, maintaining necessary records, and ensuring that current and new products meet stringent quality and regulatory requirements. This position involves significant collaboration with various internal departments at Insulet, as well as external suppliers and contractors, to address issues related to supplier quality, quality management systems, materials, product support, and audit support. Key aspects of the role include effectively communicating supplier quality performance, collaborating on supplier selection, leading efforts to improve supplier performance, and positively impacting product quality. The role is based at the Acton, MA site and requires approximately 25% travel.

Requirements

Experience in plastic injection molding. Knowledge in mold tool design, material selection, design for manufacturability (DFM), cosmetic criteria definition, and process qualification.
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.
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.

Nice To Haves

Prior co-op or internship experience is preferred.
Experience with plastics manufacturing or materials is a strong plus.

Responsibilities

Responsible for supplier quality engineering (SQE) deliverables to support Plastics category sourcing strategies and continuity of production.
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.
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 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.