Quality Systems Manager

Our Company

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

• 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.

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 8 years of experience. Or Master’s Degree with 6 years. Or 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.