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-conformance rates. Initiate and oversee root cause analysis (RCA) activities,



ensuring effective corrective and preventive actions (CAPA) are implemented.

Reporting and Coordination:

- Provide input for periodic reports and maintain transparent communication with the headquarter team regarding project progress, challenges, and outcomes.

Audits and Assessments:

- Participate in both internal and external audits using MDSAP methodology. Ensure that all audit findings are addressed and closed within the required timelines.

Your Success is Grounded In:

Educational Background:

- A Bachelor's or Master's degree in Engineering, MCA, or a related field with an excellent academic track record.

Quality Management Experience:

- 4-8 years of successful experience in Quality Management within the medical device software development lifecycle, particularly in a distributed international environment.

Knowledge of Software Product Development:

- Familiarity with the latest trends in software product development (e.g., Trunk-Based Development, Continuous Delivery, DevOps) and their application in the medical device industry.

Advanced Analytical Skills:

- Proficiency in quality tools for metrics data analysis and decision-making. Ability to interpret data and make informed decisions that drive continuous improvement.

Software Development Lifecycle Knowledge:

- Experience managing the full lifecycle of software medical device development, from product definition through to end-of-life support.

Audit Experience:

- Experience conducting audits or participating in audits, with a preference for experience in the medical device industry using MDSAP methodology.

Communication and Organizational Skills:

- Excellent communication and presentation skills, with the ability to effectively moderate discussions and present to all levels of the organization.

Problem-Solving Expertise:

- Strong critical thinking skills and the ability to resolve high-impact, complex problems across cross-functional teams.

Proficiency in Tools:

- Advanced knowledge of MS Office tools (Word, Access, Excel, PowerPoint, and Outlook). Ability to use these tools for documentation, reporting, and presenting key findings.

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