Quality Assurance Manager (Danbury)

About the Role Quality Manager

We are looking for a detail-oriented, compliance-driven Quality Manager to help advance the development of our diagnostic medical device software while also supporting broader Quality Engineering and management responsibilities. This position plays a key role in ensuring our medical devices meet the highest standards of quality through strong documentation practices, structured development processes, and adherence to regulatory requirements.

Key Responsibilities

• Support Quality Management System activities and product development across software, mechanical, and electrical programs.
• Collaborate with software and medical device development teams to embed quality and regulatory requirements throughout the software development lifecycle and device development process.
• Define, implement, and maintain SOPs, work instructions, templates, and quality records for device and software design, development, and testing.
• Lead investigations, CAPA plans, and drive closure of customer complaints, nonconformances, and related issues.
• Oversee documentation control processes, ensuring accuracy, traceability, and compliance with regulations.
• Support the creation and upkeep of essential deliverables, including :
• Software Requirements Specifications
• Design History Files
• Risk Management Files (ISO 14971)
• Verification & Validation protocols and reports
• Requirements for testing traceability matrices
• Ensure compliance with IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR 820, and other applicable standards.
• Partner with cross-functional teams (RA / QA, Operations, Engineering, R&D) to assess, audit, and continuously improve medical device and software development processes.
• Support internal and external audits, including remediation activities when required.
• Contribute to continuous improvement initiatives by identifying gaps and implementing practical solutions.
• Act as a quality advocate, offering guidance on documentation best practices to software, design, manufacturing, and other functional teams.
• Provide support across all aspects of Quality Engineering.

Qualifications

Preferred Qualifications