Senior Director, Quality Assurance
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.
This role will lead the quality manufacturing, quality systems, and quality design engineering functions for the organization. The responsibility of this role includes quality oversight of the design history process, including design verification and validation activities, design transfer, quality assurance engineering, manufacturing in-process development activities, product risk management requirements, software and artificial intelligence development, post market evaluation process as well as product reliability. We are looking for someone that possesses excellent management and people skills to lead the quality team as well as provide vision and direction for future quality improvements across the organization.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Manage, mentor, and lead the design and manufacturing quality team members.
• Develop and implement quality driven improvements across design and manufacturing processes.
• Provide design quality engineering leadership to cross-functional product teams, including new product development.
• Oversee quality management system requirements.
• Participate in the design control and review processes, including quality planning.
• Actively participate in risk management, dFMEAs, pFMEAs, troubleshooting and root cause analysis for new and existing products.
• Oversight of the PDA, NCR and MRB process.
• Participate in design and manufacturing quality related issues.
• Participate as quality lead in the product quality executive team meetings.
• Participate in management review.
• Quality oversight related to medical device software verification and validation activities, including use of artificial intelligence according to global regulations.
• Quality oversight with sterilization processes, including validation and routine processing requirements.
• Manage and validate upgrades to clean rooms and administer an effective environmental monitoring program.
Minimum of 10 years industry experience in medical device design and manufacturing quality engineering. Minimum of 5 years management experience. A working knowledge in the following areas:
• Subject matter expert in medical device design controls and risk management regulations (ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745, UK MDR, ISO 14971).
• Experience with intravascular catheters and/or console systems, preferred.
• Medical device software experience.
• Experience with sterile product.
• ASQ Certified Quality Engineer (CQE), preferred.
• Thorough knowledge of medical device engineering design principles and process flow.
• Experience in sterilization process management including validation.
• Experience validating water systems and clean rooms.
• Six sigma green belt or black belt, preferred.
• Experience with lean manufacturing and root cause analysis (A3, 5 whys).
• Able to effectively manage workload and deliverables.
• Excellent verbal and written communication skills.
• Thrives in a small size company and cross-functional team driven environment.
• Possess strong organization skills.
• Responsible team player that takes initiative and has a solution driven mindset.
• Working knowledge of Electronic Quality Systems and Microsoft office applications including Word, Excel, PowerPoint, Outlook, and MS Project.
Bachelor’s degree in engineering or related discipline.
"*" indicates required fields