Educational Requirements

Bachelor of Engineering, Bachelor Of Technology

Service Line

Engineering Services

Responsibilities
Be a part of core project team and support the quality engineering across the entire development cycle.
Lead product risk management, usability, reliability and design validation efforts for recent product development and design change projects.
Lead the development and implementation of design verification and validation plans with project design lead.
Lead the development of Critical to Quality (CTQs), design input and output documents.
Lead the fixture qualification and test method validation.
Participate and implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management and ensure compliance to CTQs and safety requirements.
Manage electronic document control and version control on all project related documents.
Ensure adherence to the quality systems and design assurance SOPs.
Lead usability, reliability, testing, verification and validation testing internal and local vendors.
Provide statistical testing and reliability plans.




Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g.

Project Design Development

Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 whys analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality.

Technical and Qualified Requirements
QMS Knowledge of Regulatory standards CFR820 , ISO 13485 14971, 60601
Hands on experience on Risk Management.
Valuable understanding of Post Market Survey and complaint handling.
Design plan Medical Process DQC Deviation and CAPA preferred.

Preferred Skills
Foundational- >Development process generic- >Medical Device development process- >Medical Device
Technology- >Quality models/improvement frameworks- >ISO 13485

📌 Design Quality Assurance Professional Medical Pune
🏢 Infosys
📍 Pune