Quality Assurance Manager

Consultant | Medical Devices | QARA United States & Europe🔭

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.

• 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
• 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.

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
• 3–5+ 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 pre‑market guidance) is a plus.

Mid‑Senior level

Full‑time

Quality Assurance

Medical Equipment Manufacturing