Insulet Corporation · 3 days ago
Senior Supplier Quality Engineer (Onsite - Acton, MA)
Acton, MA
Full-time
Onsite
Senior Level
$85K/yr - $127K/yr
5+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Sr. Supplier Quality Engineer will lead a team focused on ensuring that materials and components from suppliers meet quality standards, collaborating closely with suppliers and internal teams to enhance supplier performance and manage quality-related risks.
Health CareMedicalMedical Device
Responsibilities
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, auditing the first tier and critical sub-tier suppliers for their onsite quality, capability, technology and/or process related requirements
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 (e.g., CAPA, audits, certifications, FMEAs)
Issue and drive Supplier Corrective Action Report (SCAR) to resolve issues. Participate in root cause analysis of supplier caused non-conforming product and ensure product quality concerns are adequately addressed by the supplier. Drive corrective action and continuous improvement activities that directly impact performance for assigned suppliers
Support remediation efforts for suppliers displaying low quality performance and resolve issues related to nonconforming materials or services
Lead monthly quality performance reviews with high defect suppliers to drive defect reduction and report progress
Manage Supplier Quality-related risks; develop and implement supplier risk mitigation strategies as appropriate. Serve as the escalation point for critical supplier quality issues, driving resolution and communicating impact to leadership
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
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Electronics / Electrical / Biomedical Engineering or equivalent education/experience
Solid knowledge and expertise in problem solving related to manufacturing processes of PCBAs, PCBs, and electronic sub-assemblies. Strong understanding of SMT, ICT, FCT, and reliability testing
5–8 years of experience in Quality Assurance within FDA, ISO, or other regulated environments
Solid understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
Familiarity with global regulatory requirements
Preferred
Ability to analyze supplier performance data and present actionable insights to drive improvement
Excellent time management skills and ability to multi-task and methodically manage project milestones
Working knowledge of EN 60601 and ISO 62304. Certifications such as ASQ CQE, Six Sigma, or Lead Auditor (ISO 13485) are a plus
Strong communication skills and ability to work across multiple levels of the organization
Comfortable managing priorities in a dynamic, high-energy environment
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase