Quality Engineer/ Senior Quality Engineer

What You will do:

**Responsibilities and duties**

+ Risk Management, Design Inputs review, Design History File Document review, Design Output Document review, V&V protocols and reports review,.
+ Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
+ Participate in design reviews during various phases of NPD or Remediation for EU MDR.

+ Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.

**What You Need:**

**Required skills:**

+ Bachelors in Mechanical/Biomedical/Biotech Engineering.
+ Good analytical and problem-solving skills.
+ Basic Knowledge of EU MDR.
+ Good understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
+ 3-7 years of relevant work experience.
+ Experience on NPD process and various phases of new product development.
+ Knowledge of ISO 14971, IEC ...