QA Engineer managing Corrective and Preventive Action program in compliance with regulatory standards. Supporting Quality Management System activities in the Medical Device industry.
DF
Hybrid Staff Software DQA Engineer – Partner Management
Posted 6 hours ago
About the role
- Staff Software DQA Engineer leading quality assurance for partner management and integration. Ensuring compliance and interoperability for digital health products at Insulet Corporation.
Responsibilities
- Represent Design Assurance organization to support new product development and sustain activities for partner integration products and features
- Support partner-focused design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements
- Ensure shared compliance with global regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 82304) for Class II and III devices
- Support design controls, risk management, usability, cybersecurity, and AI/ML validation for interoperable products and systems throughout the product lifecycle
- Ensure seamless integration of digital products with partner system components including hardware, firmware, and enterprise platforms
- Continuously improve partner-relevant processes to support product excellence in a fast-paced environment
- Serve as a subject matter expert on existing partner integrations, providing expertise for pre/post-market risk assessments and support to internal/external design teams
- Lead alignment efforts with Insulet QA/RA leadership to resolve emerging partner issues, confirm strategic direction, and deliver consistent messaging to external partners
- Maintain partnership quality metrics and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives
- Manage the QMS process for inbound/outbound partner communications, assessments, and records retention
Requirements
- Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field; masters degree preferred
- 8+ years in design quality assurance within the medical device or medical digital health industry, preferably software focused
- Experience with medical device / regulated software development lifecycles with emphasis on the software quality engineering aspects
- 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) and ISO 13485 quality system standards
- Working knowledge of IEC 62304/82304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k)
- Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.)
- ASQ, CSQE or other software quality certificates are beneficial.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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