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(3 - 7 Years) "Stryker" Hiring: Quality Engineer On Jan 2020 @ Bangalore



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Company:         Stryker

Website:            www.stryker.com

Eligibility:        B.Tech/BE

Experience:       3 - 7 yrs

Location:           Bangalore

Job Role:          Quality Engineer

JOB SUMMARY:

Company Profile:

Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

Job Description:
1. Primarily responsible for Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of CER.

2. Knowledge of EU MDD and FDA QSR, any other regulations is nice to have

3. Knowledge of EU MDR may be an asset

4. Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.

5. Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.

6. Expert-level knowledge of current industry standards for New Product Development and risk management practices.

7. Good knowledge of Design Control, NCs, CAPAs and quality tools (FMEA etc.)

8. You will drive coordination with different departments (such a R&D, BML, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant and effective.

9. Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).

Candidate Profile:
Qualification/Experience:
B.Tech/BE in Mechanical Engineering, Electrical or Electronics.

Experience: Strong work experience of 3 - 7 years with good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)

Required Skills:
1. Any ASQ certification is preferred

2. Lead Internal Auditor Certification is preferred – such as ISO 13485:2016

3. Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.

 













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