Sr. Quality Engineer / Quality Engineer - Quality Assurance

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Delivers results.A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks

What you will do:

• 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.
• 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.

• 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).

What you will need:

• Education: B.Tech/M.Tech in Mechanical Engineering / Computer Science / Biomedical
• 5+ years’ experience in new product development focused on quality engineering related activities.
• Good interpersonal and communication skills
• Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
• 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.