Quality Engineer/ Senior Quality Engineer
Stryker Global Technology Center Pvt Ltd.
Job Description
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.