Clinical Quality Associate

Duties:

• Will be supporting clinical studies, preparing submissions, conducting site inspections, and performing ongoing audits and risk assessments for vendors. The candidate should have experience with CTMS and EDC systems
• Support over 40 studies, all class III medical devices in US and globally
• They promote a culture of empowerment, collaboration, and continuous learning, allowing employees to thrive in a dynamic and innovative environment.
• Employees work in self-managing teams management structure, which empowers employees to take ownership of their work and make decisions independently. This autonomy and trust can be highly motivating for those who thrive in a self-directed environment

Qualifications:

• Should have at 5 years of Medical Device experience and 3+ years of experience in clinical quality system compliance and auditing in the Medical Device industry.
• Must have supplier quality management experience.
• Working knowledge of inspection management and strong working knowledge of Good Clinical Practices (GCP) and all applicable regulations.
• Knowledge in 21CFR Part 11 and application of predicate rules.