HR Professional at Stryker
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Stryker - Quality Engineer - ISO/QMS (3-6 yrs)
1.1. Job Title : Quality Engineer
Reports to :Team Leader
1.2. Roles and Responsibilities :
- 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.
1.3. Desired Profile :
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.
Based at Division : SGTC
Based at Location : Gurgaon