Roles and Responsibilities :

- Primarily responsible for : 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.

- Responsible to ensure provisions of Design Control processes are followed and associated reviews are conducted.

- 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.

- Expert-level knowledge of current industry standards for New Product Development and risk management practices.

- 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.

Desired Profile :

Education : B.Tech/BE in Mechanical Engineering

Experience : 3-7 years

- 3+ 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 :

- Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)

- AQE should drive coordination with different departments (such a R&D, BML, Regulatory, Clinical) 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 62366, 60601-1 family of standards.

- 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.

- Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.

- Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.

Based at Division : SGTC

Based at Location : Gurgaon

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