Stryker Corporation is Hiring for Senior Quality Engineer - Mechanical

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Delivers results. A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks

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 Literature 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 the manager.

What you need:

• B. Tech / M.Tech Mechanical, Biotechnology with 5-7 years of work experience
• Hands-on experience of Complaint handling and product investigations process
• Hands-on experience of the 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
• Demonstrated ability to work effectively with various workgroups 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.
• 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)