Insulet Corporation
Medical Device
StaffSoftwareDQAEngineer,PartnerSystemsIntegrations
“Staff Software DQA Engineer, Partner Systems Integrations at Insulet Corporation. Skills: Quality Assurance, Systems Integrations, Regulatory Compliance, Cybersecurity. Lead quality assurance across SDLC. Ensure regulatory, cybersecurity, quality compliance”
What You'll Achieve.
Ensure regulatory, cybersecurity, and quality compliance; Drive interoperability, risk management, and system-level quality; Ensure seamless integration of digital products; Deliver consistent messaging to external partners
Industry & Context.
analytical and problem-solving skills
What They're Looking For.
Must Have
8+ years in medical device/software quality engineering, knowledge of regulatory standards and design controls, Experience with digital health technologies and cybersecurity, Ability to collaborate cross-functionally, manage complex, fast-paced projects, Experience with medical device / regulated software development lifecycles, Experience in the development and implementation of effective Design Control Systems, Exposure to quality decision-making, risk management, and quality engineering, Experience with software mobile applications, cloud-based systems, and cybersecurity, Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), Working knowledge of ISO 13485 quality system standards, Working knowledge of IEC 62304/82304, Working knowledge of ISO 14971, Working knowledge of IEC 62366, Working knowledge of IEC 60601, Working knowledge of FDA guidance documents on software development, Working knowledge of FDA guidance documents on cybersecurity, Working knowledge of FDA guidance documents on submission requirements for 510(k)
Nice to Have
ASQ, CSQE or other software quality certificates
What You'll Do.
Lead quality assurance across SDLC
Drive interoperability
Guide design controls
Guide partner integration strategies
Guide continuous improvement efforts
Serve as subject matter expert on integrations
Manage quality metrics
Support pre- and post-market activities
Represent Design Assurance organization
Support partner-focused design quality strategies
Ensure shared compliance with global regulations
Support design controls
Ensure seamless integration of digital products
Continuously improve partner-relevant processes
Provide expertise for risk assessments
Support internal/external design teams
Lead alignment efforts with Insulet QA/RA leadership
Resolve emerging partner issues
Confirm strategic direction
Deliver consistent messaging to external partners
Maintain partnership quality metrics
Maintain key performance indicators
Conduct regular reviews and analyses
Drive continuous improvement initiatives
Manage QMS process for partner communications
Manage QMS process for partner assessments
Manage QMS process for records retention
How You'll Work.
Team & Collaboration
Working cross-functionally; Collaborate cross-functionally; Collaborate and communicate with individuals at multiple levels within and outside an organization
Communication Scope
Excellent verbal and written communication skills
Process & Methodology
Manage complex, fast-paced projects, Manage multiple responsibilities concurrently, Prioritize and manage critical project timelines
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