14/06 Neha Taneja
HR Professional at Stryker

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Stryker - Quality Engineer - ISO/QMS (3-6 yrs)

Gurgaon/Gurugram Job Code: 455664

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)

Personality :

- 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

Women-friendly workplace:

Maternity and Paternity Benefits

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