We are seeking an experienced Quality Manager to lead and implement quality culture initiatives within our Product Line and across the organization. This position will be responsible for driving continuous improvement, ensuring compliance, and managing risk throughout the entire lifecycle of software medical device development.
You'll Make a Difference By:
Driving Quality Culture:
- Foster awareness and promote a solid focus on quality, enhancing customer satisfaction, particularly during the product development process. Lead the implementation of quality culture initiatives within your team and across the organization, ensuring that the defined processes are followed and continuously improved.

Ensuring Compliance:
- Guarantee that products comply with legal and normative requirements. Tailor processes as needed to meet both business and statutory requirements, ensuring the highest standards of product quality.

Risk Management:
- Effectively manage and review product risk activities, including performing risk analysis, generating risk management reports,



and ensuring appropriate mitigation strategies are in place.

Collaboration with Cross-functional Teams:
- Work closely with onsite teams and other cross-functional departments to ensure alignment with headquarter expectations, facilitating effective communication and collaboration on quality initiatives.

Quality Management Planning:
- Define and implement a robust quality strategy, ensuring that the quality management plan is followed throughout the complete lifecycle of the medical device, from product definition to end of support.

Design Reviews and Compliance:
- Act as an independent reviewer for design reviews in compliance with QSR 820, documenting the results and ensuring proper closure of any open issues or non-conformities.

Process Improvement & CAPA:
- Lead the process improvement efforts within the organization, identifying opportunities for increased efficiency, reduced costs, and lower non-conform

📌 Engineer Quality Management (Bengaluru)
🏢 University Of Cambridge
📍 Bengaluru