Sr Supplier Quality Systems Specialist (Hybrid - Acton, MA.)

Sr Supplier Quality Systems Specialist - Functional Excellence

Reporting to the Supplier Quality Systems Manager, the Sr Supplier Quality Systems Specialist - Functional Excellence is responsible for driving functional operational excellence within the Global Supplier Quality Engineering Team at Insulet.

The Sr Supplier Quality Systems Specialist will ensure supplier quality governance which includes creating best-in-class work instructions, procedures, and policies that define how Insulet selects, qualifies, and manages supplier quality.

The role is responsible for developing and monitoring workflows and controls in PLM and ERP systems. The Quality Systems Specialist is responsible for managing and maintaining the approved supplier list, tracking supplier history records, and overseeing related documentation to ensure compliance with quality system requirements.

The role ensures current products and new projects meet regulatory and quality requirements for medical devices. This position collaborates cross-functionally with departments such as Senior Management, Operations, IT, Engineering, Procurement, New Business Development, and Regulatory Affairs, as well as with external suppliers, contractors, and partners. The role focuses on driving supplier quality initiatives, supporting quality management systems, and contributing to both new product development and ongoing product support.

This role is accountable for leading internal and external audits, ensuring the organization maintains a state of continuous audit readiness. This includes proactively identifying and mitigating compliance risks, maintaining robust documentation practices, and fostering a culture of quality across supplier engagements. The Senior Quality Systems Specialist will also ensure that audit findings are addressed effectively and that quality system standards are consistently upheld.

Facilitate the development of meaningful, actionable KPIs aligned with key supplier quality imperatives. Lead monthly global supplier quality operational reviews to assess performance against these KPIs, document outcomes, and ensure timely tracking and closure of resulting actions.

Responsibilities include :

• Drive process improvements across global supplier quality operations to enhance efficiency and standardization across sites.
• Develop, revise, and maintain Global Supplier Quality System documentation.
• Partner with site and global teams to design and deliver training on quality system procedures.
• Review and approve Quality Management System documents, protocols, and reports, ensuring compliance with ISO 13485 and 21 CFR Part 820.
• Lead QMS remediation initiatives to address gaps and eliminate system-wide risks.
• Manage core supplier quality processes including SCARs, EQARs, Supplier Evaluations, Continuing Assessments, Supplier Audit scheduling and tracking, Component NCMRs etc.
• Monitor supplier performance trends and metrics, report insights and drive action.
• Oversee the site-level Approved Supplier List and guide global teams on ASL governance and monitoring.
• Maintain supplier quality records within ERP and PLM systems; support workflow development and optimization.
• Collaborate with Supplier Commodity teams to achieve functional objectives and KPI targets.
• Lead and support internal and external audits; drive timely and effective corrective actions.
• Facilitate monthly SCAR review board to drive timeliness, effectiveness and adequacy and completeness of SCARs.
• Support risk management activities and ensure alignment with applicable standards and regulations.
• Facilitate the development of meaningful KPIs for supplier quality initiatives; lead global operational reviews to assess performance, document outcomes, and track actions to closure.
• Perform other relevant duties as assigned to support the Supplier Quality function, with a focus on Quality Management System compliance and process-driven initiatives.

Required Skills and Competencies include :

Education and Experience :

Note : This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.