Quality Engineer - Medical Device Development
Our company is seeking a Quality Engineer to drive the development of medical devices. The ideal candidate will have experience in quality management and be able to lead cross-functional teams.
This role requires a strong understanding of regulatory requirements, including ISO 13485 and FDA regulations. The successful candidate will be able to interpret and apply these regulations to ensure compliance.
* Responsibilities:
* Drive daily implementation and continuous improvement of the quality management system (QMS).
* Collaborate with R&D to develop and review technical documentation.
* Provide QA support for regulated manufacturing.
* Coordinate and manage critical quality processes.
* Interpret relevant international standards to ensure compliance.
Required Skills & Qualifications
* Education: Bachelor's Degree in Engineering, Science, or related field.
* Experience: Minimum of 5+ years' recent experience in Medical Device Quality or Design Assurance role.
* Regulatory Expertise: Strong, recent experience interpreting and applying major regulations.
* Skills: Exceptional attention to detail, strong analytical and problem-solving abilities.
* Team Player: Excellent communication and influencing skills with proven ability to collaborate effectively across teams.