Quality Assurance Manager (Danbury)
Skills AllianceDanbury, CT, USjob_description.job_card.variable_hours_ago
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- serp_jobs.job_card.part_time
job_description.job_card.job_descriptionBachelors 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. 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.
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
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Quality Assurance Manager • Danbury, CT, US
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