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Full-time
bachelor degree, postgraduate degree
Posted 37d ago
~40 hrs/week
Responsibilities
Manage complaint handling and product investigations for medical devices, including root cause analysis and risk assessments. Develop PMS plans, PSUR reports, and lead process improvement initiatives to ensure regulatory compliance.
Requirements
Requires a B.Tech or M.Tech in Mechanical or Biotechnology with 5-7 years of experience in complaint handling and risk management. Proficiency in ISO 14971, CAPA, and medical device regulatory standards is essential.
Full job description
Work Flexibility: Hybrid or Onsite
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.
Travel Percentage: 20%
Related keywords
Medical DevicesComplaint HandlingRoot Cause AnalysisRCAISO 14971ISO 13485ISO 9001FDA 21CFR Part 820CAPA7 QC ToolsPMSPSUREUMDRGDPRisk ManagementDHR
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com.
Facts:
● 2024 Sales: $22.6 billion
● Industry: Medical Instruments & Supplies
● Employees: 53,000 worldwide
● 44+ Manufacturing and R&D Locations Worldwide
● $1.5 billion spent on research and development in 2024
● ~14,200 patents owned globally in 2024
● Products sold in ~75 countries
● Fortune 500 Company
● 9 consecutive years as one a World's Best Workplace
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How many Manufacturing jobs are open in Gurugram, India right now?
There are currently 246 open manufacturing positions in Gurugram, India listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Gurugram, India?
Companies currently hiring include Fluor Corporation, Stryker, Amazon, PwC, Reckitt, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Gurugram, India?
Yes — 54 of the 246 open manufacturing positions offer remote or hybrid work (2 remote, 52 hybrid).
How do I apply for Manufacturing jobs in Gurugram, India?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.