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QA Engineer-Design Quality typically serves as the quality representative on the cross-functional project team, works closely with the project team leader.
Provides quality assurance and regulatory requirement support and typically works as a member of one or more new product development and/or sustaining engineering projects.
Responsible for minimizing risk to the organization associated with product design and realization efforts and assists in ensuring robust medical device product designs under governing international standards and regulatory requirements.
Major on-going responsibilities for this role, but not limited to:




Is a member of Pune engineering team and has the responsibility and authority for ensuring Quality System requirements are established and maintained in accordance with applicable quality procedures of Varian Product Life Cycle (PLC)
Participate in reviews of designs and design documentation to ensure that all domestic, international engineering practices, Quality System documentation, laws and regulations are being met consistently.
Support Quality group during internal/external audits with respect to internal Quality System documentation and all appropriate regulations.
Review ECN’s to ensure compliance to Quality System, QSR and International standards and requirements for Product Life Cycle (PLC) and sustaining activities.
Ensure that product development projects and changes to existing products are conducted in compliance with all appropriate regulations and standards.
Work with teams to ensure successful transfer of new products to manufacturing. Review production pro

📌 Quality Assurance Engineer (India)
🏢 Siemens Healthineers
📍 India