Quality Engineer/ Senior Quality Engineer
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.
Experience on NPD process and various phases of new product development.
Knowledge of ISO 14971, IEC 62366, 60601-1 family of standards
Expert-level knowledge of current industry standards for New Product Development and risk management practices.
Preferred Skills:
Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
Change Management
QMS