Stryker Senior Advance Quality Engineer in Gurugram, India

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.

Education

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

Experience:

  • Experience: 3-6.5 years

Work From Home: No

Travel Percentage: None

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com