Quality Engineer
Open Hand Solutions
Full-time
Remote
Job Description
- 5+ years experience in a software engineering organization in a development or quality engineering role
- Understanding of FDA, ISO, HIPAA, SOC2, and other regulations and standards
- Sound knowledge of IEC 62304: Medical device Software – Software life cycle processes.
- Working knowledge of different SDLCs (software development life cycle), particularly agile scrum
- Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
- Demonstrated ability to advocate for product excellence and quality.
- Knowledge of cloud-based technologies such as Amazon Web Services
- Experience working in a regulated environment preferably in software medical device R&D
- Must possess strong project management skills as well as the ability to manage multiple tasks simultaneously
- Demonstrated ability to test, review defects and inspect software and/or code
- Work with leadership and team members to solicit process requirements and drive organizational change for continuous process improvements.
- Perform risk analysis and develop mitigation strategies as appropriate.
- Lead, mentor, and work with the local and remote testing teams across the globe to drive verification and validation efforts
Skills:
- Understanding of Quality Management Systems for Medical Devices
- Familiarity or experience with Corrective Action and Preventive Action (CAPA) process
- Strong experience in Documentation and Reviews
- Excellent interpersonal communication skills
Location: Chandigarh & WFH
Please email cv on info@openhandsolutions.com, with notice period , current gross per month and expected gross per month , immediate joiners preferred