Senior Supplier Quality Engineer (Onsite - Acton, MA)

The Sr. Supplier Quality Engineer plays a key role in ensuring that materials, components, and services provided by suppliers meet Insulet’s quality and regulatory standards for medical devices.

Requirements

• Inspire and lead a team of Supplier Quality Engineers for day-to-day quality issues
• Coach and mentor team members on various supplier-related and internal Quality System issues
• Engage in selection and evaluation activities of new potential suppliers
• Partner with suppliers and internal teams to ensure raw materials and components meet specifications and quality requirements
• Communicate design and inspection changes to suppliers, ensuring alignment with internal procedures
• Evaluate supplier inspection processes, provide recommendations and validate supplier’s ability to determine part acceptance
• Lead and support supplier-driven quality improvement initiatives
• Develop, maintain, and update supplier quality documentation and systems
• Monitor supplier performance using scorecards and metrics
• Issue and drive Supplier Corrective Action Report (SCAR) to resolve issues
• Support remediation efforts for suppliers displaying low quality performance
• Lead monthly quality performance reviews with high defect suppliers
• Manage Supplier Quality-related risks; develop and implement supplier risk mitigation strategies as appropriate
• Serve as the escalation point for critical supplier quality issues
• Manage Supplier change notification process for supplier quality related activities
• Maintain accurate supplier records in ERP and PLM systems
• Participate in internal and external audits, including root cause analysis and CAPA implementation
• Review and approve material/component documentation and qualification protocols

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs