Senior Quality Engineer - Complaints Handling

Stryker; Gurugram District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Stryker, a global leader in medical technologies, seeks a QA Engineer for its Gurgaon site to lead complaint handling and product investigations of medical devices. You will perform visual, functional, dimensional inspections and RCA on field-returned products, and maintain complete complaint files reflecting all activities.

You will also review processes, DHR, CAPA, NC occurrences, and analyze literature to identify complaints.

Qualifications

• 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.

Responsibilities

• 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
• Holding self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities

Skills

Complaint handling

Root cause analysis

CAPA

Risk assessment

Engineering drawing

Analytical ability

Cross-functional collaboration

Education

B.Tech Mechanical

M.Tech Mechanical

Biotechnology

Tools

7 QC Tools

Problem Solving Tools

Job description

• 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.
• 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 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.

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.