Insulet Corporation · 1 day ago
Sr. Supplier Quality Engineer, Indirect Purchase Family (Onsite - Acton, MA)
Acton, MA
Full-time
Onsite
Mid, Senior Level
$85K/yr - $128K/yr
5+ years expInsulet Corporation is committed to transforming the lives of people with diabetes through its innovative Omnipod product platform. The Senior Supplier Quality Engineer for Indirect Commodity will lead quality oversight and strategic engagement with indirect service suppliers, ensuring compliance with quality, regulatory, and business requirements.
Health CareMedicalMedical Device
Responsibilities
Own and execute the quality strategy for Indirect service suppliers
Ensure compliance with ISO standards (e.g., ISO 11137, 11135, 17025, 14644) and FDA regulations for sterilization, testing, and software services
Evaluate Indirect suppliers for QMS relevance and define type and extent of control required based on the nature of service provided. Maintain ASL control for these suppliers
Lead qualification, onboarding, and periodic evaluation of service suppliers
Conduct supplier audits and assessments to verify supplier capabilities and compliance
Maintain supplier records in ERP and PLM systems
Develop and review quality agreements, validation protocols (IQ/OQ/PQ), and risk assessments (pFMEA, Control Plans etc.)
Support CAPA investigations and nonconformance resolution
Partner with Procurement and Supplier Development teams to align supplier selection with business needs
Communicate inspection and process changes to suppliers and internal stakeholders
Monitor supplier performance using scorecards and KPIs
Drive supplier-led quality improvement initiatives
Provide technical guidance on sterilization, software validation, and lab testing protocols
Support internal and external audits and regulatory inspections
Qualification
Required
Bachelor's degree in Engineering
5–8 years of experience in Quality within FDA, ISO, or other regulated environments
Solid understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
Preferred
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