Job Title DQE - AV&I;

Job Description

Job Title : DQE - AV&I;

The Senior Design Assurance Engineer will support design controls and quality management associated with the development, transfer and sustaining initiatives for the medical devices.

You are responsible
- Lead all quality elements of Design Controls and product Design History Files.
- Drive Quality norms associated with design engineering projects.
- Support integration of Risk Management processes throughout the product lifecycle from initial development through post market surveillance in accordance with Philips processes and global standards.
- Lead Quality Plan initiatives associated with Risk Management and Quality System integration.
- Support integration of post market surveillance processes into Design Controls and Sustaining initiatives through analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.
- Support the Regulatory Affairs department for submissions and respond to submission questions.




- Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives.
- Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS.
- Transfer Quality deliverables for current products and sustaining projects to manufacturing and operations quality and supplier quality teams.
- Support internal and external audits.
- Acts in full compliance to all applicable regulatory requirements and Philips Quality policies.

Minimum required Education:
Bachelors / Masters Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.

Minimum required Experience:
Minimum 8-10 years of experience with Bachelors/Masters in areas such as Quality Engineering, Safety Engineering, R&D; Engineering or equivalent.

Preferred Certification:
Six Sigma Green Belt

Preferred Skills:
- Design Quality Management
- Experience in ISO 14971, 21 CR 820, IS

📌 DQE - AV&I Professional (Bengaluru)
🏢 Philips
📍 Bengaluru