More jobs:
US_East | QA/Quality Engineer_L
Job in
Andover, Anoka County, Minnesota, 55304, USA
Listed on 2026-06-06
Listing for:
Datum Software, Inc
Full Time
position Listed on 2026-06-06
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
Role Name:
Senior Software Quality Assurance Engineer
Work Location:
Andover, MA
Role Overview
As a Senior Quality Engineer (Design Quality Engineer) for a medical device manufacturing client in the Greater Boston region, you will ensure end-to-end design quality and compliance across the full product development lifecycle for Class II/III medical devices, including software-driven systems and active implantable products. You will collaborate with cross-functional teams to enforce design controls, risk management, and SDLC best practices from concept through commercialization and post-market phases.
Key Responsibilities:
- Serve as quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
- Establish and maintain DHF, DMR, and DHR with full traceability from user needs through verification and validation evidence
- Lead risk management activities including hazard analysis, FMEA, and risk file development, ensuring integration of risk controls into design and validation
- Provide quality oversight of software SDLC activities in compliance with applicable standards (e.g., IEC 62304) and system-level risk management
- Review and approve design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
- Support verification, validation, and design transfer activities ensuring alignment between design outputs and production processes
- Lead or support CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
- Support internal and external audits (FDA, Notified Body, ISO) and contribute to regulatory submissions (e.g., IDE, PMA, EU MDR)
Required Skills:
- 10+ years of experience in Quality Engineering within regulated medical device development (Class II/III preferred)
- Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
- Working knowledge of applicable standards and regulations (21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
- Experience supporting software quality within SDLC and software risk management principles
- Experience with risk management tools (FMEA, hazard analysis) and integration into product development
- Experience supporting audits and regulatory submissions with ability to defend quality documentation
- Strong analytical, documentation, and communication skills across cross-functional teams
- Experience with eQMS/PLM tools and CAPA/defect management systems
A global business and technology transformation partner helping organizations accelerate digital and sustainable transformation. The organization operates in 50+ countries with 340,000+ employees and leverages expertise in AI, generative AI, cloud, data, engineering, and industry solutions.
"All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran”
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