Quality Engineer I at Zimmer Biomet in Bengaluru, Karnataka, IN

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

Job Summary:

The Quality Engineer is an entry level position responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.

Work Location: Bangalore Work Mode: Hybrid (3 Days in office)

How You'll Create Impact

Principle Duties and Responsibilities:

• Ensure compliance with global regulations and recognized standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR).
• Review, maintain and approve Design History Files (DHF) and Risk Management Files (RMF).
• Identify and mitigate design risks using FMEA and other tools.
• Support design verification and validation activities.
• Supports design and change control processes.
• Collaborate with design teams to embed quality standards.
• Author, review and approve documentation in Quality capacity.
• Define and control Critical to Quality (CTQ) characteristics.
• Assist with regulatory submissions and audits.
• Analyse quality data to identify trends and improvement areas.
• Support quality improvement initiatives.
• Support root cause investigations and CAPA activities.
• Supports design transfer and sourcing transfers with Supplier Quality counterparts.
• Supports customer complaints investigations.
• Management of product nonconformance, hold and field action records and activities.
• Support audit, inspection, and regulatory submission readiness activities as needed.

What Makes You Stand Out

Your Background

Education/Experience Requirements

• Bachelor’s degree with 1-3 year’s of related experience.
• Familiarity with 21 CFR 820/ISO13485/IEC 62304 and other government/ISO standards preferred.
• Experience in regulated industries.
• Medical device experience preferred.
• Strong computer skills (MS Office Suite and Adobe).

Physical Requirements

Travel Expectations

EOE/M/F/Vet/Disability