What are the responsibilities and job description for the Quality Assurance Manager position at Skills Alliance?
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
- 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.
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.
