Here at Aquabiliti, we are a fast-growing, successful organization and have an opening for a Director of Quality Assurance for Class ll/lll Medical Devices and/or Injectable Pharmaceuticals.
Key responsibilities for this role will include:
- Leading all QA/RA functions and related activities.
- Maintenance and enhancement of the QMS in compliance with 21 CFR parts 820 & 210-211 and ISO 13485.
- Being the lead role during regulatory (FDA and ISO) audits.
- Enhancing product quality monitoring, identifying and prioritizing complaint trends, as well as leading the charge on a highly effective and robust CAPA system.
- Participation in product life cycle development from concept to commercialization.
- Implementation of strategies to achieve and enhance the individual growth of team members.
Key Requirements for this role include:
- A Bachelor’s Degree in Engineering, Mathematics, or Science (Master’s Degree a plus).
- At least 5 years minimum Quality Assurance and Regulatory Affairs related experience, with demonstrable success in a managerial role.
- Class II/III Medical Device Experience.
We’ve experienced exceptionally strong growth, exceeding 30% plus each year, and are highly focused on innovation, which is just part of the reason why we’ve entered into a strategic partnership with Ropella, the world’s leading executive search and consulting firm.
Our company culture is warm, friendly, and very entrepreneurially driven. If you are an assertive leader, have experience in Research, Product Development, Testing, Validation and Manufacturing, and would like to be a key player in driving our company’s continued success, please connect with Timir Patel right away at 615 833 2633 or send him an email at firstname.lastname@example.org.