Job Summary

Position Overview

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.
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.
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

Bachelors 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 those with a bachelors degree.
3 years of progressive work experience in medical device supplier quality, quality, manufacturing, or engineering for those with a masters degree.
Experience with plastics manufacturing or materials is a strong plus.
Additional Information
This position is based at our Acton, MA site.
Estimated travel: ~25%, with flexibility based on business needs. Position Overview: The Senior Design Assurance Engineer is responsible for ensuring new products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative to improve awareness, visibility, and communication on all quality initiatives in order to support departmental, functional and corporate quality goals and priorities. He/she can effectively communicate with all levels of the organization. Responsibilities: Ensures new product introduction quality deliverables are created and properly executed (e.g. Project Quality Plan and Risk Management Plan). Works with teams to establish measurable, valid product requirements. Supports Risk Management activities from product Concept through Commercialization. Supports DHF content completion, integrity, and regulatory and standards compliance. Identifies gaps, collaboratively communicates and works with team to resolve gaps. Review and approve design control documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. Provide guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution. Supports manufacturing process development & qualification for new product commercialization and product changes. Provides project direction, coaching, and mentoring for engineering and technical team personnel. Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues. Performs other duties as required. Education and Experience: BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience. Masters degree in engineering or technical or scientific discipline preferred. 5-7 years experience in the FDA regulated environment. Experience in Quality in an FDA regulated industry. Experience with QSR Part 820, ISO 13485 and ISO 14971. Experience with ETO sterilization methods preferred. Experience with methods and standards for the design, verification, and validation of medical device products. Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments). Experience with word processing, spreadsheet, database programs. Skills/Competencies: Effective verbal and written communication skills. Effective collaboration and communication with individuals at multiple levels in an organization. Ability to organize and judge priorities. Ability to generate and maintain accurate records. Ability to follow up with task owners to close out open items. Strong problem solving / root cause analysis skills. Good verbal (including presentation) and written communication skills, especially technical report writing. Ability to generate and maintain organized and accurate records.

Additional Information:

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.