3 Days Left: PQL Specialist

2 weeks ago

Bengaluru, Karnataka, India cyient Full time
Job Description

Your role

- You ensure state-of-the-art quality in software development for medical and non-MD applications for optometrists.
- You operate out of India closely supporting the ZEISS SW development team
- You create, review, and approve the Technical Documentation in conformance with product requirements and for international regulatory approval (e.g., MDR, 21CFR820, IEC 62304, cybersecurity)
- You are a competent partner for R&D, product management and operations in the evaluation of applicable standards and implementation in SW verification and validation
- You participate in the design transfer to suppliers including the related documentation
- You play a key role in the change management of the applications and support the change owners in the compliant implementation of the change process throughout the entire product life cycle
- You develop risk management strategies for agile SW development (ISO 14971)
- You participate in complaint and non-conformance management investigation and ensure root cause analysis and documentation
- You are responsible for post-market surveillance process activities (PMS, PSUR and PMCF)
- You contribute relevant KPI for management & quality reviews
- You support internal and 3rd party audit activities
- You support the introduction and implementation of digital platforms for design and QMS processes

Requirements

Education:

- You have a Bachelor's or Master's degree with a technical orientation or a comparable relevant discipline

Work Experience:

- 5+ years of experience in the development and advancement of quality management and quality improvement measures, ideally in the field of medical software

Skills Required

Design,Quality Management Systems (QMS),Regulatory Approvals,Risk Management

Location

Bengaluru, India

Desirable Skills

Design,Quality Management Systems (QMS),Regulatory Approvals,Risk Management

Designation

Associate

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