Staff Engineer - Software Quality Assurance in Gurugram at Stryker Corporation

Date Posted: 10/23/2020

Job Snapshot

Job Description

  • Detail-oriented process improves: Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Self-directed imitators: People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Meticulous documenters: Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

  • 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.
  • Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
  • Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.
  • Participate in design reviews during various phases of NPD.
  • Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
  • Expert-level knowledge of current industry standards for New Product Development and risk management practices.

What you will need:

  • Strong experience of 6-9 Years in Risk management, Risk Table creation & Analysis, FMEAs, Quality Inspection procedure, Literature Review, Device Master Record, Design Validation & Quality Training plan.
  • BE/BTech or Equivalent Software or Electronics/Electrical (Preferably Software) with experience in quality role in engineering /manufacturing environment
  • Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
  • Exposure to any Programming language & on Software Testing concepts.
  • Design & User Validation exposure.
  • Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
  • AQE should drive coordination with different departments (such a R&D, Test, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant and effective.
  • Experience on NPD process and various phases of new product development.
  • Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
  • Design and User Validation.
  • Participant and/or champion for Corrective Action and Preventative Action (CAPA) process.
  •  Good to have knowledge of IEC 62304 standard for Medical device software.
  •  Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
  • Good interpersonal and communication skills.

Work From Home: Occasional

Travel Percentage: 10%


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