Insulet Corporation · 1 day ago
Sr. Supplier Quality Engineer (Onsite - Acton, MA)
Acton, MA
Full-time
Onsite
Mid, Senior Level
$87K/yr - $131K/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 plays a key role in ensuring that materials, components, and services provided by suppliers meet Insulet’s quality and regulatory standards for medical devices, supporting both new product development and ongoing production.
Health CareMedicalMedical Device
Responsibilities
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
Support supplier onboarding for new product components, ensuring timely evaluations and approvals aligned with product launch timelines
Lead and support supplier-driven quality improvement initiatives, including root cause analysis and corrective actions
Develop, maintain, and update supplier quality documentation and systems
Implement ongoing monitoring of supplier process controls, including process capability on critical to quality features
Execute Product Part Approval Process (PPAP) steps to build quality early in the product life cycle to qualify parts into production
Monitor supplier performance using scorecards and metrics (e.g., DPPM, CAPA, audits, certifications, FMEAs)
Participate in internal and external audits, including root cause analysis and CAPA implementation
Review and approve material/component documentation and qualification protocols
Contribute to risk management activities and ensure compliance with applicable standards and regulations
Partner with early-stage R&D teams to support supplier selection, and quality inspections for new product development
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Engineering
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
Demonstrated ability to build and maintain effective working relationships with external suppliers to ensure alignment on quality standards, timelines, and continuous improvement initiatives
Experience working on new product development initiatives
Working knowledge of EN 60601 and ISO 62304
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