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Advanced Quality Engineer in Gurugram at Stryker Corporation
at Stryker Corporation
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 www.stryker.com.
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
Together with our customers, we are driven to make healthcare better.
- $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.
Primarily responsible for:
- Primarily responsible for: Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, Code Review, Test log test plans, Software verification and Validation.
- Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
- Responsible to ensure provisions of software life cycle processes are followed and associated reviews are conducted.
- Conduct design reviews during various phases of NPD.
- Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
- Work with team to develop robust software architecture as per quality and regulatory requirements.
- Expert-level knowledge of current industry standards for software engineering and risk management practices ideally from the domain of safety critical applications
- Demonstrated ability to apply software and system quality management practices in efficient and effective ways while being compliant.
- Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
- Good interpersonal and communication skills.
Education: B.Tech/BE in Computer Science or System Engineering
- Experience: 3+ years
(2+ years experience in new product development focused on quality engineering related activities.Strong preference given to medical device industry experience)
- Demonstrated organizational and written/verbal communication skills.
- Demonstrated ability to self-motivate
- Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
- Demonstrated ability to prioritize tasks in a deadline-driven environment.
Specific Job Skills:
- DQA shall drive coordination with different departments (such a R&D, Testing, Regulatory, Post Market Quality) 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 62304, 60601-1 family of standards.
- Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001)
- Awareness on programming languages, embedded software & tools.
- Ability to review Defects (Electrical & Software)
- Ensure that software, mechanical, electronic, and material/implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.
- Provide expertise in establishing good specifications and protocols like requirements, architecture, detailed design, verification & validation planning, etc.
- Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
- Conduct and moderate all kind of Design Reviews (e.g. SRS Reviews, source code reviews, etc.).
- Establish overall system test design in cooperation with test engineering.
- Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews, code inspections and the other practices mentioned above.
Work From Home: No
Travel Percentage: Up to 25%