Position – Quality Engineer – PMS
Company – Stryker
Location – Gurgaon, Haryana, IN
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Who we want:
- 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 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:
- B. Tech / M.Tech Mechanical, Biotechnology with 2-5 years of work experience.
- Hands on experience of PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis.
- 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
- 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.
- 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)
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.