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(3 - 6 Years) "Stryker" Hiring: Quality Engineer On Sept 2018 @ Gurgaon



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Company:         Stryker

Website:            www.stryker.com

Eligibility:          BE/B.Tech

Experience:       3 - 6 yrs

Location:           Gurgaon

Job Role:           Quality Engineer/Sr 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. Risk management, Risk Table creation & Analysis, FMEAs, Quality Inspection procedure, Literature Review, Device Master Record, Design Validation & Quality Training plan.

2. Sound knowledge of IEC 62304: Medical device Software – Software life cycle processes. This also includes good exposure to all the phases of Software development life cycle (SDLC).

3. Product risk assessment as per ISO14971.

4. Support validation programs for new product development.

5. Responsible for initiating, reviewing (Includes Design reviews & Phase Reviews), documenting and approving Engineering Change Orders (ECO’s).

6. Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability.

7. Partners with the operations team to develop and maintain a robust internal and external supply chain. Contribution examples include the performance of supplier audits, risk assessment/mitigation, and coaching.

8. Develop procedures for incoming, in-process and final inspections for new product development.

Candidate Profile:
Education:
BE/B.Tech or Equivalent Software or Electronics/Electrical (Preferably Software) with experience in quality role in engineering /manufacturing environment.

Experience: 3 - 6 Years as Quality Engineer / Sr. Quality Engineer

Technical Skills:
1. Exposure to Software development life cycle & validation process.

2. Able to do risk assessment for medical devices as per ISO 14971.

3. Knowledge of IEC 62304 standard for Medical device software.

4. Knowledge of IEC 606061-1 family of standards will be a plus.

5. Knowledge of Human Factors Engineering/ Usability Engineering IEC62366.

6. Understanding of Quality Management Systems for Medical Devices.

7. Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.

 













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