Advance Quality Engineer de Gurugram em Stryker Corporation

Data de Postagem: 8/19/2019

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The company

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 medical technologies, including orthopaedics, medical and surgical, and neurotechnology & spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries around the world.  For more information, please visit our website at

Stryker Corporation (NYSE:SYK) announced that it has been named as one of the 2017 Best Companies to Work for in the United States.  This is the seventh consecutive year Stryker has been named to the list, and the company was ranked 19 out of 100

Our mission

Together with our customers, we are driven to make healthcare better.

Quick Facts

  • $11.325 billion in annual sales in 2016, 73% in U.S.
  • Annual revenue has grown for 37 straight years
  • 18% CAGR (compound annual growth rate) in sales over 37 years
  • ~33,000 employees globally
  • Products sold in 100+ countries
  • 44 manufacturing and research & development locations worldwide
  • Included in the Standard & Poor’s 500 Index
  • Ranked # 287 on Fortune Magazine’s “FORTUNE 500” list for 2016
  • Ranked # 5 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2016
  • Ranked # 21 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2016
  • Spent $715 million on research and development in 2016, consistently spend between 5.0 – 6.3% of sales on R&D annually since 2000
  • 4,898 patents owned globally in 2015
  • Initial public offering of stock was in 1979
  • Listed on the New York Stock Exchange under ticker SYK

Seeking a passionate leader of self, people & process, and organization with the following attributes:

Sets direction.  An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.

Builds organizational capability.  A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.

Inspires others.  A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.

Champions talent development.  A manager who focuses on maximizing the ability, potential and contributions of themselves and others.   Fosters an environment where people can excel through developing, coaching and rewarding performance.

Delivers results.  A driven player/coach who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks.

Position profile

Advance Quality Engineer

Responsibilities and duties

  • 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.

Experience/skills required

  • Bachelors in Mechanical/Biomedical/Biotech Engineering.
  • Good analytical and problem-solving skills.
  • Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
  • 4-8 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.

Work From Home: No

Travel Percentage: None

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