- Establish and implement the companies Quality Management System (QMS)
- Oversee all quality-related activities at the company
- Ensure continuous improvement of the QMS along with GMP and GLP compliance
- Ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, customer requirements, and product specifications.
- Prepare, oversee, and conduct internal and external audit programs.
- Direct CAPA initiatives and measure effectiveness of corrective actions
- Advise and train companies personnel on the preparation of documents regarding to QMS implementation
- Review and approve changes to controlled documents and processes such as SOPs, specifications, etc.
- Build Quality function across programs and mentor direct reports
- Bachelor's degree in Engineering or related field.
- Minimum 8 years of experience in a Quality function in a Medical Device company.
- Leadership experience in a Quality function
- Experience implementing quality process improvement initiatives.
- Experience with document control, document review and auditing.
- Knowledge and experience with standards (ISO 13485, IEC 60601, 21 CFR 820, 21 CFR 11)