Assoc Mgr, Quality Engineering-Digital & SW

Essential Duties and Responsibilities:
- Review and approve product development & digital projects documents, including plans, protocols and reports, to ensure compliance with quality requirements as defined in procedures, standards and guidelines
- Provide quality guidance on maintenance of product Design History Files and Risk Management Files in accordance with relevant Quality System and other regulatory requirements.
- Work with regulatory affairs as needed to guide teams in meeting quality/regulatory requirements based on the regulatory plan/strategy or assessment.
- Other tasks assigned by supervisor
Qualifications:
- Knowledge in the areas of digital products & software development process.
- Understanding of medical device & software product registration requirements.
- Well organized, pay attention to details, and be able to articulate customer needs and incorporate into work.
- Demonstrated leadership, teamwork, and communication skills.
- Project management experience.
- Fluent oral and written English.
Education and/or Experience:
- Scientific University degree (Computer Science, Software Engineering, Electronic Engineering, etc.)
- Knowledge & experience of ISO 13485, ISO 14971, IEC 62304, IEC 82304, FDA, ICH, and EMEA regulations
- Knowledge & experience of related NMPA standards & regulations (GB9706, YY9706)
- Min. 5 years experience in medical device, digital products & software development
Experience in leading project teams and Quality Initiatives (processes, systems, improvements) in an international environment