System Engineer

Zimmerbiomet

Bangalore, Karnataka
Permanent
Full-time

5 days ago
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Job DescriptionAt 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 recognised.
What You Can ExpectThe 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 ImpactRegulatory 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
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 OutPreferred 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 BackgroundRelevant 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 & ToolsQuality & 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

Bachelors degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related technical field (or equivalent experience)
EOE/M/F/Vet/Disability

Zimmerbiomet