Quality Engineer in Gurugram at Stryker Corporation

Date Posted: 12/3/2019

Job Snapshot

Job Description

Seeking a passionate mechanical engineering professional with the following attributes:

Who we want :

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

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
  • Creation PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis.

What you need:

  • Having sound knowledge on complaint handling with total experience of 3-7 year
  • Educational background of  B.Tech / M.Tech in Mechanical or Biotechnology y
  • 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
  • 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.
  • Applied understanding of GDP, ISO 9001 & ISO 13485
  • Good understanding of FDA 21CFR Part 822 / 820

Work From Home: Not available

Travel Percentage: None

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