Description
• Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements).
• Manage Document Control system, including the Change Order process.
• Manage the CAPA, Complaints, SCAR, and Audit Findings processes.
• Lead supplier management, including maintaining the Approved Supplier List for Critical/Crucial Suppliers and facilitating the re-evaluation of suppliers, including review of supplier data as appropriate.
• Own the development of Quality Metrics, and coordinate quality data collection and analyses for use in Management Reviews.
• Lead for regulatory body audits.
• Manage the Internal and Supplier Audit processes.
• Lead Management Review and Quality Planning.
• Lead and manage site training program.
• Track and report on company Quality KPIs.
• Organize and lead monthly company meetings on established KPIs and Trends.
• Coach, counsel, and train direct reports. Monitor performance and take appropriate action as necessary.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Other projects and tasks as assigned.
Requirements
EXPERIENCE/SKILL REQUIREMENTS:
Minimum of 7 years of experience in a Medical Device environment, 3-5 years supervisory experience. A working knowledge in the following areas:
• Internal and External auditing
• Corrective and Preventive action
• Excellent verbal, written and presentation skills
• Detailed organization skills
• Team player with excellent communication skills
• ISO 13485 and FDA Quality System Regulation
• Strong knowledge of Quality Systems programs including but not limited to Document Control, Record Control, Change Control, Training, and Device Master Record (DMR)
• Demonstrated experience in administration of electronic systems such as PLM, ERP, and MDM systems
• Strong communication skills, both written and oral; Ability to lead meetings and presentations
• Must be able to effectively communicate up/down and across different levels of the organization
• Demonstrated ability to work with MS Word, Teams, Excel, Project and Visio
• Demonstrated ability to independently troubleshoot issues with electronic systems
• Demonstrated experience in training users on systems and processes within an electronic environment
• Certified Internal Auditor preferred
• Lean and Six Sigma Green Belt Certified preferred
EDUCATIONAL REQUIREMENTS:
Bachelor’s with at least 7 years of experience. Or Master’s Degree with 6 years. 15+ years of experience may be considered in lieu of a degree for a candidate who can demonstrate the combination of experience, training, and education to be capable of successfully fulfilling all duties and responsibilities of the position.
Skills Required
- Minimum of 7 years experience in a Medical Device environment
- 3-5 years supervisory experience
- Internal and external auditing experience
- Corrective and Preventive Action (CAPA) management
- Experience managing Document Control, Record Control, Change Control, Training, and Device Master Record (DMR)
- Knowledge of ISO 13485 and FDA Quality System Regulation
- Experience administering electronic systems such as PLM, ERP, and MDM
- Demonstrated ability to use Microsoft Word, Teams, Excel, Project, and Visio
- Ability to troubleshoot electronic systems and train users on systems/processes
- Excellent verbal, written, and presentation skills; ability to lead meetings and communicate across levels
- Bachelor's degree (or Master's with 6 years experience); 15+ years experience may be considered in lieu of degree
- Certified Internal Auditor
- Lean and Six Sigma Green Belt Certification
What We Do
Gentuity is a commercial-stage medical technology company pioneering next-generation intravascular imaging devices, specifically high-frequency OCT, to provide interventional cardiologists with complete vessel visualization and real-time insights for optimizing PCI procedures.
