Job Listing
Director of Quality Assurance
Job Type
Permanent
Employment
Full Time
We are actively searching for an experienced Director of Quality Assurance to work onsite for an opportunity paying up to $150,000, plus bonus, based on experience.
Job Responsibilities
- Minimum of 5 years of US Quality Assurance experience with both drug and medical devices
- Bachelor’s or Master’s Degree in Engineering, Regulatory Science, or a related area
- Knowledge of US regulatory requirements and the ability to interpret and apply regulations (FDA, ICH, and others) to specific projects
- Demonstrated knowledge and understanding of the drug and device development process
- Supervisory experience required
- Ability to manage quality audits and compliance with regulatory directives
- Experience in FDA device and drug submissions
- Familiarity with quality management systems and FDA audits
Qualifications
- Develop and execute quality assurance strategies in line with company goals
- Oversee quality assurance operations ensuring regulatory compliance
- Collaborate with product development teams, regulatory affairs, and executives
- Regularly update the company’s quality assurance plan
- Contribute to FDA device and drug submission strategies
- Support company affiliates in quality assurance areas
- Conduct and manage quality audits of suppliers and partners
- Ensure compliance with company procedures and regulatory commitments
- Manage quality assurance budget
- Perform other duties as assigned by management
