Supplier Quality Engineer (Onsite - Acton, MA)

Insulet Corporation•Acton, MA

1d•Onsite

About The Position

The Supplier Quality Engineer is responsible for ensuring supplier governance and governance of related quality systems. The Engineer creates, monitors, and reports on metrics that show the health and capability of the supplier quality system. The individual maintains records and databases needed for those metrics. The Engineer ensures current products and new projects meet quality and regulatory requirements for medical devices. The Engineer interfaces with other Insulet departments (e.g. Sr. Management, Manufacturing Operations, Production Operations, Supplier Development Engineering, Design Engineering, Information Technology, Engineering, Procurement, New Business Development and Regulatory Affairs) as well as suppliers, contractors, and other external parties on issues related to supplier quality, quality management systems, materials, product support and external and internal audit support. Effectively communicating supplier quality performance metrics, status, and requirements are critical to the success of the position. Other significant impacts will come from collaborating on the selection of qualified suppliers, leading the efforts to quantify and improve supplier performance, and providing a positive impact on the quality of new and existing products through a global footprint.

Requirements

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.
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.
Bachelor’s degree in Mechanical Engineering, Industrial Engineering or a related field.
0-3 years of progressive work experience in medical device supplier quality, quality, manufacturing, or engineering.

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.
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.
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.