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Insulet Corporation · 2 days ago
Supplier Quality Engineer
Acton, MA
Full-time
Onsite
Mid Level
$65K/yr - $98K/yr
2+ years exp
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Insider Connection @Insulet Corporation
Responsibilities
Responsible for Design Control initiatives to develop appropriate Design History File documents. Review and approve new product documentation, as required.
Collaborate with Project Management to optimize Design Control process and develop Sustaining Quality Engineering process.
Review and approve Design Control documents and protocols.
Serve as the Design Control expert to the organization.
Develop and deliver Design control training for the organization.
Support CAPA activities.
Support Risk Management activities and ensure compliance to standards and regulations.
Performs other duties as assigned.
Qualification
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Required
BS degree in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience
Minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience
Experience in the development and implementation of effective Design Control Systems
Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices
Working knowledge of EN 60601, Safety requirements for medical electrical systems
Working knowledge of ISO 62304, Medical Device Software – Software Life Cycle Process
Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint)
Demonstrated experience organizing and maintaining large documentation sets
Ability to follow up with task owners to close out open items
Familiarity with structured phase-gate product development processes
Familiarity with FDA, ISO, and other international regulatory requirements
Preferred
Effective verbal and written communication skills
Experience collaborating and communicating with individuals at multiple levels in an organization
Ability to organize and judge priorities
Ability to generate and maintain accurate records
Skilled in computer use including word processing, spreadsheet, and database applications
Able to work effectively in a high-stress, high-energy environment
Company
Insulet Corporation
Insulet Corporation, 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.
1,001-5,000 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
Trends of Total Sponsorships
2023 (14)
2022 (29)
2021 (46)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$50MKey Investors
OrbiMed
2007-05-15IPO· nasdaq:PODD
2006-02-16Series E· $50M
Leadership Team
Shacey Petrovic
President & Chief Executive Officer & Co-Founder
Ana Maria Chadwick
Chief Financial Officer
Recent News
2024-05-31
2024-05-16
2024-05-13
Company data provided by crunchbase
