Senior Quality Engineer - Complaints Handling

PowerToFly; Gurgaon; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading global medical technologies company is seeking a qualified candidate in Gurgaon, India to handle complaints and investigate medical devices. The role requires B. Tech / M.Tech in Mechanical or Biotechnology with 4-7 years experience, strong analytical ability, and hands-on risk management experience. Familiarity with ISO standards and FDA regulations is preferred. The candidate will perform inspections and ensure accurate documentation within a multi-national team environment.

Qualifications

• 4-7 years of work experience in complaint handling and product investigations.
• Experience in risk management process as per ISO 14971.
• Knowledge of medical device complaint handling processes is advantageous.

Responsibilities

• Handle complaints and product investigations of medical devices.
• Perform inspections and maintain complaint files.
• Review and analyze clinical and PMCF reports for complaints.

Skills

Complaint handling

Product investigations

Risk management

Problem-solving methodology

Root cause analysis

Analytical ability

Education

B. Tech / M.Tech in Mechanical or Biotechnology

Tools

ISO 14971

ISO 9001

ISO 13485

FDA 21CFR Part 822

Job description

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, 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.
• Other tasks as assigned by manager.

What you need:

Required:

• B. Tech / M.Tech Mechanical, Biotechnology with 4-7 years of work experience
• 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.
• Hands on experience of 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)

Preferred:

• Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
• Demonstrated 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.

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.