We are seeking a skilled Medical Devices Quality Assurance Specialist to join our team.
Key Responsibilities
1. Apply quality assurance expertise across multiple areas of a developing Quality Management System, ensuring compliance with regulatory standards and industry best practices.
2. SUPPORT the certification process and maintain compliance with relevant regulatory requirements, including ISO 13485 and FDA regulations.
3. Assist with design verification and validation activities to ensure high-quality medical devices.
4. Maintain document control through electronic QMS systems and perform related administrative tasks, such as updating quality manuals and procedures.
This role offers a unique opportunity for a motivated quality professional to apply their knowledge in a fast-paced medical device start-up environment, where innovative patient-centric technologies are being developed to improve quality of life.
Requirements
* Bachelor's degree in engineering, science, or a related field is required.
* A minimum of 2 years' experience in a medical device or supplier environment is necessary.
* Familiarity with regulatory requirements, such as ISO 13485 and FDA regulations, is essential.
The ideal candidate will have excellent communication and problem-solving skills, be able to work independently, and demonstrate strong attention to detail.