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Senior Advance Quality Engineer in Gurugram at Stryker Corporation

Date Posted: 1/10/2019

Job Snapshot

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Job Description

1.1 Roles and Responsibilities

  • Primarily responsible for: Advance Quality Planning, Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, Device Master Record Documents review.
  • Conduct Risk Management per ISO14971 to ensure the safety and effectiveness of product.
  • Responsible to ensure provisions of New Product Development processes are followed and associated reviews are conducted.
  • Initiate & Conduct Design Reviews during various phases of New Product.
  • Responsible for initiating, reviewing, documenting and approving Engineering Change Orders (ECO’s).
  • Work with team to develop robust verification, validation & manufacturing transfer strategies to ensure product compliance, safety, reliability & effectiveness.
  • Support Process Validation.
  • Define process controls – inspections FAI, pfmea, PPAP, Control Charts, and Quality Matrices etc.
  • Participant in supplier selection & evaluation.
  • Support manufacturing and operation in resolving manufacturing and quality issues as required during new product development.
  • Develop procedures as required for new product development. Reviews procedures to ensure compliance (21 CFR 820 & 13485).
  • Lead product quality related projects. Supports the business in addressing and solving quality problems.
  • Understanding of customer need and the team to achieve process/product compliance, safety, reliability & effectiveness.
  • Conduct internal audits & participate during internal and external audits.
  • Provide inputs for new product development process improvements and for adherence to QMS requirement.

Technical Skill Set

  • Experience on Medical Device Development process.
  • Experience on New Product Development process and various phases of new product development.
  • Experience on Risk Management, different Risk Analysis tools and techniques.
  • Experience on ISO 14971, 60601-1 family of standards.
  • Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001).
  • Understanding of design requirement specification, detailed design requirements, engineering Drawings, Verification & Testing documents, Product Validation documents.
  • Experience on reviewing Design Outputs, Device Master Record, and Design History File. 
  • Experience with various Quality Management & Quality Control tools.
  • Understanding of the concepts of PPAP & Advance Product Quality Planning.
  • Experience on Basic Statistics.


  • B. Tech / B.E / M. Tech / M.S. – Mechanical / Electrical or Electronics Engineering


  • Experience: 3-6.5 years

Work From Home: No

Travel Percentage: None

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