Quality Assurance & Regulatory Affairs Manager

Responsibilities

1. Manage the QA/RA team
2. Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards
3. Maintain and monitor our quality system within the company: changes, CAPA, Non-conformities, Complaints, PMS, continuous improvement, trend analysis, etc.
4. Train all employees to the QMS, and assess skills, knowledge and QMS application
5. Perform internal audits to assess the company compliance with our QMS
6. Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information
7. Work with our Notified Body to maintain current certifications and achieve award of a CE mark and FDA approval on new products
8. Build knowledge and maintain surveillance of the many relevant quality standards
9. Provide technical support and resolve quality issues with suppliers, customers or auditors including introduction of new or re-designed components and processes
10. Present technical data to internal / external audit and inspection groups as required

Requirements

1. Minimum of 5 years of Medical device QA/RA experience
2. In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management
3. Quality Management experience in a manufacturing/production environment
4. Conscientious and responsible
5. A keen eye for detail and a results driven approach
6. Strong communication and presentation skills
7. Excellent organizational and leadership skills
8. Proficient in MS Office
9. In depth understanding of quality control procedures and relevant legal standards
10. Excellent math abilities and working knowledge of data analysis/statistical methods