Supplier Quality Engineer (Onsite - Acton, MA) jobs in United States
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Insulet Corporation · 3 hours ago

Supplier Quality Engineer (Onsite - Acton, MA)

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes. The Supplier Quality Engineer will support the selection, qualification, and management of external suppliers, ensuring product quality meets Insulet's requirements while effectively communicating quality metrics to the organization and suppliers.

Health CareMedicalMedical Device
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Maintain approved supplier list and supplier history records in accordance with quality system requirements
Assist with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications
Maintains accuracy of Supplier Audit Reports and Supplier Profile
Plans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements
Prepares detailed trip reports and Audit Reports to document audit findings and observations
Communicates quality issues to suppliers as needed and aids development of corrective actions
Initiate and follow up on supplier corrective actions for both audit deficiencies and internal non-conformances to ensure timely closure
Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility
Tracks and trends supplier performance, taking remedial action as needed
Conduct and assist with internal audits
Assist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance
Participate in developmental and departmental training
Support Site during external audits (i.e. BSI, FDA, Customer)
Performs other duties as required

Qualification

Quality System RegulationISO 13485 standardsSupplier auditingCQE certificationCQA certificationMedical device experienceWordExcelOutlookPowerPointCommunication skillsInterpersonal skills

Required

BS/BA Degree or Equivalent
2 to 4 years of experience in quality in the medical device industry
Medical device or related industry experience in a technical position
Working knowledge of the Quality System Regulation (FDA 21CFR Part 820) and ISO 13485 quality system standards
Strong verbal and written communication skills, internal and external to the company
Good interpersonal skills in dealing with suppliers, peers and other functional areas
The ability to prioritize multiple competing deliverables simultaneously
Must be proficient in Word, Excel, Outlook and Power Point
Ability to lift up to 20 pounds
International and Domestic travel required, up to 50%
This position requires on-site working (requires on-site office/plant/lab work)

Preferred

Auditor training certification to ISO 13485, 17025 or other industry QMS Standard preferred
CQE and / or CQA certification is desirable

Benefits

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

Company

Insulet Corporation

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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.

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 Company
Total Funding
$629.5M
Key Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO

Leadership Team

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Ashley McEvoy
President & Chief Executive Officer
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Ana Maria Chadwick
Chief Financial Officer
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Company data provided by crunchbase