Quality Engineer in Gurugram at Stryker Corporation

Date Posted: 7/12/2019

Job Snapshot

Job Description

Seeking a passionate mechanical engineering professional with the following attributes:

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.

Responsibilities and duties

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.

Experience/skills required

•Complaint handling and Product investigations of medical devices•Perform Visual, Functional and Dimensional inspection of returned products.•Root cause analysis of field returned products•Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.•Risk management –Risk assessment•Review of design and process documents for root cause analysis•Review of Process flow, DHR, inspection plans, measurement techniques, GRR’s etc.  •Review and analyze Literatures such as Clinical Reports, PMCF Reports etc. to identify Complaints•Sound knowledge on complaint handling process of medical devices•Hands on experience of problem solving methodology and root cause analysis•Good Understanding of Risk Management process•Strong Analytical ability.•Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).•7 QC tools, Problem Solving & CAPA.•Demonstrated auditing experience in a manufacturing environment.•Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.•Demonstrated organizational and written/verbal communication skills.•Demonstrated ability to self-motivate•Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.•Demonstrated ability to prioritize tasks in a deadline-driven environment. •Hands on Experience of Complaint handling and product investigations process•Good Understanding of and root cause analysis 

Work From Home: No

Travel Percentage: None

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