What you will do:
Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review, Review and approval of ECO/ECR.
Effective change control for NPD and Sustaining Products.
Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
Participate in design reviews during various phases of NPD.
Work with team to develop robust verification, Design validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
What You Will Need:
Required Qualifications
Bachelor’s in computers/ IT/ Electronics.
5-7 years of relevant work experience.
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 62304, IEC 62366, 60601-1 family of standards.
Expert-level knowledge of current industry standards for New Product Development and risk management practices.
Preferred Qualifications:
Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
Strong interpersonal skills, written communication and negotiations skills.
Good analytical and problem-solving skills.
Travel Percentage: 50%