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Quality Assurance Manager (Danbury)

Quality Assurance Manager (Danbury)

Skills AllianceDanbury, CT, US
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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

  • Bachelors degree in Engineering, Computer Science, Life Sciences, or a related field.
  • 35+ years of experience in Quality Engineering, with direct involvement in medical device software development (diagnostics experience preferred).
  • Strong knowledge of IEC 62304, ISO 13485, ISO 14971, and related regulatory frameworks.
  • Hands-on experience with technical documentation, configuration management, change control, and risk management processes.
  • Familiarity with software development methodologies (Agile / Scrum) and tools such as Jira, Confluence, and Git.
  • Experience with electronic quality management systems (eQMS) is a plus.
  • Excellent written communication, organisational, and collaborative skills.
  • Ability to interpret regulatory requirements and apply them effectively within a development environment.

    • Preferred Qualifications

  • Experience supporting regulatory submissions (FDA, CE marking).
  • Certifications in Quality or Regulatory (e.g., ASQ CQE, RAPS) are advantageous.
  • Familiarity with cybersecurity standards (e.g., FDA premarket guidance) is a plus.
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    Quality Assurance Manager • Danbury, CT, US