Senior Quality Engineer - Complaints Handling

Stryker; Gurugram District; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Stryker India seeks a qualified mechanical/biotech professional to manage complaint handling and investigations for medical devices. The role requires hands-on problem solving, risk assessment and regulatory compliance, including ISO 14971, ISO 9001/13485 and FDA guidelines.

Collaboration with cross-functional teams across multinational sites is essential. You will drive CAPA initiatives, contribute to PMS/PSUR as per EUMDR, and mentor colleagues to ensure high-quality outcomes in a fast-paced

Qualifications

• Hands on experience of complaint handling and product investigations
• Experience with problem solving methods and root cause analysis
• Knowledge of 7 QC tools, CAPA and risk management per ISO 14971
• Understanding of GDP, ISO 9001 & ISO 13485 and FDA 21CFR Part 822/820

Responsibilities

• Handle complaints and product investigations of medical devices.
• Perform visual, functional, dimensional inspection & RCA of field returned products and maintain complaint files.
• Risk management – risk assessment.
• Review process flow, DHR, inspection plans, measurement techniques, GRR, and literature to identify complaints.
• Create PMS plan, PMS report, PSUR per EUMDR, trend reports and complaint analysis to promote quality practices.
• Identify and lead opportunities for process improvement and redesign of workflows.
• Mentor and inspire others to deliver high quality results.

Skills

Complaint handling

Product investigations

Root cause analysis

CAPA

QC tools

Risk management

GDP

ISO 14971

ISO 9001

ISO 13485

FDA 21 CFR 822/820

Education

B.Tech Mechanical

M.Tech Mechanical

B.Tech Biotechnology

M.Tech Biotechnology

Tools

Inspection plans

GRR

Job description

• Complaint handling and Product investigations of medical devices
• Perform Visual, functional, dimensional, functional inspection & RCA of field returned products and maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
• Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR’s etc; 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, Trend report & Complaint analysis and 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.

What you will do:

• Complaint handling and Product investigations of medical devices
• Perform Visual, functional, dimensional, functional inspection & RCA of field returned products and 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, GRR’s etc; 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, Trend report & Complaint analysis and 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.

What you need:

Required:

• B. Tech / M.Tech Mechanical, Biotechnology
• Experience - 5 years -7 years
• Hands on experience of Complaint handling and product investigations process. Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability and Risk Management process as per ISO 14971.
• 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; 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 to mentor and lead a group of individuals towards meeting business needs and set them up for future success.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.