Senior Quality Engineer - Medical Device Complaint Handling

Stryker India Private Limited; Gurugram District; Hybrid; INR 1,500,000 - 2,300,000; Full time

Job summary

Stryker India Private Limited is seeking a Senior Quality Engineer - Complaints Handling to lead complaint resolution and product investigations for medical devices. You will perform visual, functional, and dimensional inspections, conduct root cause analysis, and manage CAPA within ISO 14971 risk management framework.

The role requires handling NC/CAPA reviews, risk assessments, and collaboration with global teams while ensuring compliance with GDP, ISO 9001/13485 and FDA guidelines.

Qualifications

• Experience in complaint handling and product investigations for medical devices
• Hands-on with ISO 14971 risk management
• Knowledge of GDP, ISO 9001, ISO 13485
• Familiarity with FDA 21 CFR Part 822/820
• Ability to collaborate with multi-national teams across functions

Responsibilities

• Handle complaints and perform product investigations of medical devices
• Conduct visual, functional, dimensional inspections and RCA of field returned products
• Maintain complete complaint files reflecting all related activities
• Review NC/CAPA, risk management plan, process flow, DHR, inspection plans, and measurement techniques
• Analyze literature (clinical reports, PMCF, national registers) to identify complaints
• Create PMS plan, PMS report, PSUR per EU MDR guidelines; perform trend analysis

Skills

Complaint handling

Product investigations

Problem solving

Root cause analysis

CAPA

Risk management

Engineering drawing

GDP knowledge

ISO 9001 knowledge

ISO 13485 knowledge

FDA regulatory knowledge

Cross-functional collaboration

Education

B.Tech / M.Tech Mechanical or Biotechnology

Job description

Senior Quality Engineer - Complaints Handling

Work Flexibility: Hybrid

What you will do:

Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, Review NC and CAPA and be able to identify any occurrence of an NC. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR guidelines, Trend report & Complaint analysis. Provide technical guidance and promote quality best practices across the organization. Identify and lead opportunities for process improvement, redesign, and development of workflows. Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities. Mentor, develop and inspire others in current and future roles. Other tasks as assigned by manager.

What you need:

Required:

B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of Complaint handling and product investigations process; problem-solving methodology, root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability, and engineering drawing. Hands on experience of Risk Management process as per ISO 14971. Experience - 5years -7years Sound knowledge on complaint handling process of medical devices will be an added advantage. Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have). Good understanding of FDA 21CFR Part 822 / 820 (Good to have). Ability to collaborate and influence within matrix organizations and engage effectively with multiple stakeholders across multi-national teams.

Preferred:

Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies; ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams and mentor and lead a group of individuals towards meeting buisness needs and set them up for future success.

Travel Percentage: 20% Experience Level Senior Level