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Quality Engineer

Quality Engineer

Stryker Global Technology Center Pvt Ltd.Gurugram, India
30+ days ago
Job type
  • Full-time
Job description

Work Flexibility : Hybrid

Who we want :

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business
  • Data communicators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Dedicated achievers. People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations.
  • Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

What you will do :

  • Primarily responsible for Risk management, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File.
  • Product risk assessment as per ISO14971
  • Primary participant in new supplier selection, validation, and contract development. Assists vendors in resolving manufacturing and quality issues as required.
  • 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.
  • Develop procedures for incoming, in-process and final inspections for new product development
  • Assists / Leads in the trending and analysis of quality data (e.g. complaints, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate.
  • Authors and reviews procedures to ensure GMP and ISO 13485 compliance.
  • Lead product quality related projects. Supports the business in addressing and solving quality problems
  • Conduct internal audits & participate in corporate and FDA audits
  • Support process validation programs for new product development
  • Work with cross-functional / cross –cultural teams to develop regulatory guidelines and procedures
  • Provide inputs for NPDP for adherence to QMS and Good Documentation practices
  • Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability
  • Must have delivered multiple projects in AQE function and understand Risk Management processes in depth.

    • What you need :

  • Bachelors in mechanical / biomedical / Biotech Engineering.
  • Good analytical and problem-solving skills.
  • Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
  • 3-5 years of relevant work experience.
  • Experience on NPD process and various phases of new product development.
  • Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards.
  • Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
  • Expert-level knowledge of current industry standards for New Product Development and risk management practices.

    • Travel Percentage : 10%