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 Systems Engineer Service CAPA & Post-Market Quality is responsible for initiating, managing, and verifying the effectiveness of servicing-related Corrective and Preventive Actions (CAPAs) to ensure compliance with 21 CFR Part 820 and internal quality system requirements. This role analyzes service data, complaints, and repeat service issues to identify systemic causes, drive corrective actions, and ensure sustained improvements in device performance, reliability, and patient safety.
The role partners closely with Service Engineering, Quality, Regulatory Affairs, Manufacturing, R&D, and Field Service teams and is especially suited to complex electromechanical or robotic medical devices.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
How You'll Create Impact
Regulatory Compliance & CAPA Management
- Initiate and manage servicing-related CAPAs in compliance with 21 CFR Part 820 (Corrective and Preventive Action) and servicing controls
- Ensure CAPAs are appropriately scoped, documented, and progressed through required quality system stages
- Maintain alignment between servicing issues, complaint handling, and CAPA processes
Root Cause & Trend Analysis
- Analyze service records, field service reports, complaints, and repeat service issues
- Identify systemic failure modes, trends, and contributing factors
- Apply structured root cause analysis methodologies to servicing-related problems
Corrective & Preventive Actions
- Define, implement, and document effective corrective and preventive actions related to:
- Service procedures and work instructions
- Tools, test equipment, and fixtures
- Training programs and competency requirements
- Service documentation and manuals
- Partner with cross-functional teams to ensure actions are practical, validated, and sustainable
Effectiveness Verification
- Define and execute CAPA effectiveness checks using service metrics, recurrence rates, and post-implementation monitoring
- Verify sustained improvement and formally close CAPAs when effectiveness criteria are met
- Escalate if corrective actions fail to achieve intended outcomes
Documentation & Inspection Readiness
- Maintain complete, accurate, and traceable CAPA records
- Ensure documentation supports FDA inspections, internal audits, and management review
- Support regulatory and quality audits related to servicing and post-market quality
What Makes You Stand Out
Preferred Qualifications
- 4 to 6 years total experience in regulated medical device environments
- Experience with field service operations for capital equipment or robotic systems
- Experience linking service issues to design or process improvements
- Six Sigma, CQE, or quality-related certifications (preferred)
Core Competencies
- Strong analytical and systems-thinking skills
- Disciplined approach to CAPA management and documentation
- Ability to drive cross-functional corrective actions
- Clear communication with Quality, Service, Engineering, and leadership teams
- High ownership for compliance, effectiveness, and continuous improvement
Your Background
Relevant Technical Skills
- 4 to 6 years of experience in medical device systems engineering, quality engineering, or service engineering
- 3+ years managing or supporting CAPA processes, preferably related to servicing or post-market quality
- Demonstrated experience supporting FDA inspections or regulatory audits
- Experience with complex electromechanical devices; robotic medical device experience preferred
Technologies & Tools
Quality & CAPA Systems
- Electronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)
- CAPA initiation, tracking, and closure workflows
- Complaint handling and servicing data systems
Root Cause & Risk Analysis
- Root cause analysis tools (5 Whys, Fishbone/Ishikawa, Fault Tree)
- Trend analysis methods and dashboards
- Risk management frameworks (ISO 14971)
Data & Metrics
- Service performance metrics (repeat service rate, recurrence, MTBF/MTTR)
- Data analysis tools (advanced Excel, Power BI/Tableau preferred)
Regulatory & Standards
- 21 CFR Part 820 (CAPA, servicing, document controls)
- ISO 13485 (preferred)
- Post-market surveillance and service quality requirements
Documentation & Collaboration
- Document control and change management systems
- Collaboration tools for cross-functional reviews and approvals
Education And Experience Requirements
- Bachelor's degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related technical field (or equivalent experience)
EOE/M/F/Vet/Disability
