Insulet Corporation-posted 3 months ago
$89,850 - $134,775/Yr
Full-time • Mid Level
Hybrid • Acton, MA
Miscellaneous Manufacturing

The Sr Supplier Quality Systems Specialist - Functional Excellence is responsible for driving functional operational excellence within the Global Supplier Quality Engineering Team at Insulet. This role ensures supplier quality governance, including creating best-in-class work instructions, procedures, and policies that define how Insulet selects, qualifies, and manages supplier quality. The position involves developing and monitoring workflows and controls in PLM and ERP systems, managing the approved supplier list, tracking supplier history records, and overseeing related documentation to ensure compliance with quality system requirements. The role collaborates cross-functionally with various departments and focuses on driving supplier quality initiatives, supporting quality management systems, and contributing to both new product development and ongoing product support. Additionally, the role is accountable for leading internal and external audits, ensuring continuous audit readiness, and fostering a culture of quality across supplier engagements.

  • 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.
  • BS degree in scientific discipline or quality systems, preferred.
  • Minimum of 3-5 years' experience in Quality Systems within the medical device industry, with exposure to Purchasing Controls.
  • Demonstrated knowledge of PPAPs.
  • Experience with the application of 21CFR820, ISO 13485.
  • Experience leading or supporting FDA QSIT, MDSAP, and ISO 13485 audits.
  • Experience with electronic QMS or PLM systems, such as Arena and Agile, preferred.
  • Base salary range of $89,850.00 - $134,775.00.
  • Hybrid working arrangements.
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