Product Design Quality Sr Specialist Ii

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 patients 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 recognized.

What You Can Expect:

Ensures Zimmer Biomet and compatible products meet regulatory, quality, and customer requirements throughout the design and development process, and product lifecycle. Collaborates cross-functionally and with external partners to achieve Zimmer Biomets quality and business objectives.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)

How You'll Create Impact:

• Works as part of a team and individually, completing Quality tasks in the design and development, and change control processes.
• Coaches and mentors less experienced peers.
• Reviewer and approver of document-controlled forms.
• Leads team member training.
• Serves as site SME for multiple processes.
• Represents Quality team in global and site meetings.
• Creates project and resource plans for medium scale, moderate complexity projects.

What Makes You Stand Out:

• 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.
• Analyze 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

Your Background:

Required Skill:

• Proficient in design controls, verification, validation (design, process and software).
• CPI (Continuous Process Improvement) or NPI (New Product Introduction) experience
• Regulatory expertise: FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR
• Hands-on Design Verification & Validation (V&V) including risk-based testing
• Risk Management
• CAPA, root cause analysis, and quality improvement.
• Excellent technical documentation & cross-functional communication skills

Education and Experience Requirements

• B.S. in Engineering or related field; CQE or CRE certification preferred.
• 5-7+ years in Quality Engineering or medical device equivalent experience.
• Solid foundation in engineering principles; preferred expertise in materials science, robotics, SiMD, and SaMD.
• Equivalent education/experience combinations considered.
• Six Sigma Black Belt, DOE Proficiency Preferred
• QSIT Lead Auditor Certification Preferred
• Physical Requirements

Travel Expectations

• Up to 20%
• EOE/M/F/Vet/Disability