Global Quality & Regulatory Affairs Role - IT

Hiring for Global Quality and regulatory Affairs

KEY RESPONSIBILITIES:

- Support and engage in new product developments of software

- Ensure compliance to Quality Management System as part of the product lifecycle

- Participate in project meetings and design reviews, risk management activities, design transfer, etc.

- Review of design history files and associated design documents

- Oversee and support the development of the software test strategy, test scope and test depth

- Support the development and maintenance of the test automation and regression test suite

- Support R&D teams on data/information requirements including compliance and security aspects

- Review and approve design control deliverables and changes (ECR/ECO)

- Act as QA subject matter expert for software defects or critical issues affecting health/safety

- Ensure compliance with ISO13485, IEC 62304, FDA CFR 21 Part 820, ISO 14971, cybersecurity etc.

- Drive quality compliance projects and continuous improvement activities

- Support in audits

- Provide guidance and/or training to project teams on procedures, statistical methods, and design control activities.

Qualifications:

EDUCATION: Bachelor's or Master's degree in software engineering, business informatics or equivalent

EXPERIENCE/SKILLS:

- +4 years of relevant experience in the areas of product development and/or quality engineering using waterfall and agile methodologies (Scrum, Kanban)

- Deep understanding of ISO 13485, ISO 62304, FDA CFR 21 Part 820, ISO 14971 as well as relevant cybersecurity standards and data integrity compliance.

- Hands-on-experience with test automation infrastructure

- Hands on experience with coding languages like Type Script, C#, JavaScript, Python, VB Script

- Experience with system architecture designs including embedded systems, client-server, n-tier, web and collaboration platforms

- Understanding of software project lifecycles, test processes and tools such as JIRA

- ISTQB Certification preferred

- Pragmatic, flexible and solution-oriented.

- Analytical skills with focus on finding the right solutions in compliance with regulations.