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14/09 Neha Taneja
HR Professional at Stryker

Views:434 Applications:61 Rec. Actions:Recruiter Actions:60

Stryker - Quality Engineer/Senior Quality Engineer - Medical Devices (2-5 yrs)

Gurgaon/Gurugram Job Code: 15329

About Stryker :

- Founded in 1941 and headquartered in Kalamazoo, Michigan, Stryker Corporation engages in the development, manufacture, and marketing of orthopedic products and medical specialties worldwide. 


- Stryker Corporation is a fast-paced company with aggressive growth targets. They have historically increased revenues by 20% each year for the last 27 years. 


- Stryker's company culture prides itself on 5 tenets: service ethics, integrity, innovation, accountability, customer relationships.


- The Emerging Markets Region include 10 countries, categorized in 5 key regions: Korea, Taiwan, China/Hong Kong, Southern Asia (India and ASEAN) and South Pacific (ANZ). Stryker opened its global research and development centre in Gurgaon in April 2006, to enhance their technology innovations and boost the commercial expansion in India.

Roles and Responsibilities :

Key Responsibilities include :

- 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

Skill Set :

- 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

Please apply.

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