Quality Engineer

The Quality Engineer at Zimmer Biomet in Bangalore is an entry-level role focused on ensuring products comply with regulatory and quality standards. Responsibilities include supporting software quality activities, maintaining documentation, assisting with risk management, and collaborating with various teams. The role requires a bachelor’s degree and at least one year of related experience, with strong computer skills. Familiarity with ISO standards and experience in regulated industries are preferred. The position operates on a hybrid model, with shifts from 3:00 PM to 12:00 AM, three days in the office. The ideal candidate will have a background in medical devices or regulated industries and be comfortable working in a collaborative, cross-functional environment.

The Quality Engineer at Zimmer Biomet is an entry-level role focused on ensuring that products meet established requirements and standards through rigorous audit, inspection, and testing activities. Working within a global medical technology leader, the position collaborates with cross-functional teams, suppliers, and external experts to implement quality goals and support software development projects. The role involves maintaining quality documentation, supporting software risk management, and ensuring compliance with regulatory standards. The Quality Engineer will contribute to continuous improvement initiatives and participate in design reviews, helping to deliver robust and compliant software solutions. This position offers opportunities for professional growth within a supportive and inclusive environment.

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

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)
Shift Timing - 3:00 PM to 12:00 AM

How You'll Create Impact

• Partner with design and cross-functional development teams to support software quality activities for new product introductions.
• Contribute to software architecture, design, implementation, integration, and maintenance activities for product development projects under the guidance of more senior engineers.
• Maintain software design and quality documentation and help ensure it remains current throughout the product lifecycle.
• Support software changes, enhancements, defect corrections, and sustaining engineering activities for released products.Assist with software risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
• Support verification and validation planning, protocol development, execution, and documentation.
• Participate in design reviews and provide input to help ensure robust, compliant, and maintainable software solutions.
• Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
• Review technical documentation, including software requirements, architecture and design documents, test protocols, traceability matrices, and change records, with support from senior team members as needed.
• Help ensure software development activities align with design controls, software development lifecycle processes, and applicable regulatory expectations.
• Support troubleshooting, root cause investigations, and continuous improvement initiatives.
• Learn from senior engineers and contribute across projects and product platforms as a developing quality engineering professional.
• Support audit, inspection, and regulatory submission readiness activities as needed.

What Makes You Stand Out

Your Background

• Bachelor’s degree and at least 1 year 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

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

Responsibilities:

• Partner with design and cross-functional development teams to support software quality activities for new product introductions.
• Contribute to software architecture, design, implementation, integration, and maintenance activities for product development projects under the guidance of more senior engineers.
• Maintain software design and quality documentation and help ensure it remains current throughout the product lifecycle.
• Support software changes, enhancements, defect corrections, and sustaining engineering activities for released products.
• Assist with software risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
• Support verification and validation planning, protocol development, execution, and documentation.
• Participate in design reviews and provide input to help ensure robust, compliant, and maintainable software solutions.
• Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
• Review technical documentation, including software requirements, architecture and design documents, test protocols, traceability matrices, and change records, with support from senior team members as needed.

Skills:

• Familiarity with 21 CFR 820/ISO13485/IEC 62304 and other government/ISO standards is preferred.
• Experience in regulated industries is required.
• Medical device experience is preferred.
• Strong computer skills, including proficiency with MS Office Suite and Adobe, are necessary.

Education:

• A Bachelor’s degree is required.