Software Quality Assurance Engineer
This role is responsible for ensuring the software meets regulations and quality standards. The successful candidate will have experience in product and IT systems software development and validation, with a focus on Agile methodology and IEC 62304 compliance.
Responsibilities:
* Ensure software projects meet regulations and quality standards.
* Take ownership of software projects for regulatory compliance and champion process excellence.
* Handle software releases for commercial products.
* Create and review software lifecycle project deliverables.
* Perform risk analysis and manage software risks.
* Review software design and development documentation for compliance.
* Review traceability analysis and reports to ensure project requirements are met.
* Evaluate and disposition software anomalies.
* Create, review, and approve document change control requests.
* Provide quality input to Complaint and CAPA investigations.
* Review and update Cybersecurity documentation.
Requirements:
* Bachelor's degree in a technical or scientific field.
* Minimum 5-8 years of experience in quality or software engineering in the medical device industry.
* Team leadership skills and ability to prioritize and execute projects.
* Knowledge of ISO and FDA/Quality System Requirements.
* Strong project and time management skills.
* Familiar with Risk Management as governed by ISO 14971.
* Creative problem-solving skills and ability to work on multiple tasks concurrently.
* Proficient with MS Teams, Word, Excel, PowerPoint, and eQMS systems.
Benefits:
* Pension.
* Competitive compensation package based on experience.
* Flexible work location and occasional international travel.