Quality Engineer in Gurugram at Stryker Corporation

Date Posted: 6/28/2019

Job Snapshot

Job Description

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

Quality Engineer

Responsibilities and duties

  • 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.
  • 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.

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)
  • 3-6 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: Up to 25%

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