Position Summary:
We are seeking a dedicated Quality Specialist to join our team, reporting to the Senior Director of Quality Engineering. In this role, you will be pivotal in managing and supporting the development, maintenance, and resolution of Device Quality Management System (QMS) records. Your primary responsibility will be to enhance and uphold the quality of our medical devices. This position demands both independent work and effective collaboration with cross-functional teams in a dynamic environment. You will play a key role in ensuring that our Quality Management System adheres to medical device regulatory standards.
Key Responsibilities:
- Manage and oversee the creation, maintenance, and closure of QMS records.
- Support and drive continuous improvement initiatives to uphold product quality.
- Collaborate with various departments to ensure seamless quality management processes.
- Maintain and develop the Quality Management System in compliance with relevant regulatory requirements.
Qualifications:
- Education: Bachelor’s Degree in Science or a related field.
- Experience: 3-5 years in a medical device or combination product regulated industry.
- Regulatory Knowledge: Proficient in 21 CFR Part 820 and ISO 13485:2016.
- Skills: Strong critical thinking, analytical, and problem-solving abilities.
- Communication: Excellent written and verbal communication skills.
