Senior Manager - Design Quality & Post Market Surveillance - Medical Devices

Senior Manager Design Quality & Post Market Surveillance (Medical Devices)

Location: Gurugram (Hybrid)

Experience: 12-16 Years

About the Role:

We are looking for an experienced Quality leader from the Medical Devices industry to lead Design Quality, Post Market Surveillance (PMS), and Quality Management System (QMS) initiatives for global engineering and product teams.

This role requires strong expertise in product development quality, sustaining engineering support, regulatory compliance, and cross-functional stakeholder management.

The candidate will also lead high-performing teams and drive strategic quality initiatives aligned with global business objectives.

Key Responsibilities:

Business & Strategic Leadership:

- Develop and drive strategic plans for Quality functions including PMS, QMS, and Design Quality.

- Lead complex cross-functional programs and quality initiatives.

- Define and track KPIs, metrics, and operational goals for the team.

- Support budgeting, resource planning, and organizational growth initiatives.

- Drive process improvement and operational excellence initiatives.

Technical & Functional Leadership:

- Lead Design Quality activities across product development and sustaining engineering.

- Drive Post Market Surveillance activities and ensure compliance with global quality standards.

- Collaborate with global engineering and quality teams to ensure alignment and consistency.

- Provide guidance on technical problem-solving, risk management, CAPA, and regulatory compliance.

- Support audit readiness and quality advocacy activities.

Team & People Management:

- Lead, mentor, and develop high-performing quality engineering teams.

- Drive competency development, technical coaching, and succession planning.

- Manage performance objectives, team engagement, and career development initiatives.

- Collaborate with global stakeholders for cross-training and capability building.

Required Skills & Expertise:

Strong experience in:

- Design Quality

- Post Market Surveillance (PMS)

- Quality Management Systems (QMS)

- Product Development Lifecycle

- Sustaining Engineering

- CAPA & Risk Management

- Regulatory Compliance (FDA/ISO 13485 preferred)

- Experience leading global/cross-functional teams.

- Strong stakeholder management and program leadership skills.

- Excellent communication and people management capabilities.

Education:

Bachelors degree in Engineering or related technical field (Mechanical, Biomedical, Industrial Engineering preferred)

Preferred Background:

Candidates from Medical Device/Healthcare product organizations with strong global quality experience will be preferred

Contact: 9045052073