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 Senior Software DQA Engineer – Embedded Software
Posted 6 hours ago
About the role
- Senior Design Assurance Engineer ensuring quality and compliance in medical device product development. Collaborating with cross-functional teams on embedded software systems and regulatory requirements.
Responsibilities
- Ensure that Insulet’s medical device products meet quality, safety and regulatory requirements throughout the development lifecycle
- Focus on embedded software systems and ensure compliance with applicable standards, regulations and guidance documents
- Interface with other Insulet departments and external parties on product development and support
- Provide expert guidance on requirements, specifications, design documentation, verification plans, test protocols, and more
- Ensure adherence to Design Controls processes and alignment with Insulet Quality System, Quality System Regulation, and ISO 13485 requirements
- Support manufacturing process development and qualification activities for new product launches
Requirements
- BS degree in Computer Science, Software Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or equivalent science degree
- 5-7 years work experience in Design Assurance/Quality/Product Design and Development within an FDA, ISO, or other regulated environment
- Experience with Design Controls (FDA 21 CFR Part 820), and Design and Development /Product Realization (ISO 13485)
- Experience with Medical Device regulations (IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, and cybersecurity)
- Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS)
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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