The Medical Device Quality Manager will be largely responsible for leading optimization and maintenance of QMS, and provide expertise in ISO 13485 and FDA compliance as by part 820 CFR 21.
The successful Medical Device Quality Manager will have:
• Bachelor of Science degree in a related field (required)
• Minimum of five (5) years of experience in Quality Assurance leadership in a regulated Manufacturing environment – likely possessing a total of 10 years of overall Quality/Manufacturing experience
• Experience in Medical Device manufacturing/ISO 13485:2016/Internal Auditing/ design control/suppliers management/risk management
• Demonstrated ability to lead, manage, and develop Quality System.
Knowledge in European CE mark by MDD and other international regulations is a plus but not mandatory.
Jointechlabs (JTL) is a point-of-care regenerative medicine solutions company. With our device and technology, we enable healthcare practitioners, physicians, medical centers and hospitals to provide safe, reliable, cost-effective non-surgical interventional medicine treatments at the point-of-care without significant change in infrastructure. JTL is pioneering access to high quality nanofat, adipose-derived stem cells and cell therapies at the point-of-care. Our primary products are patented, disposable, closed loop medical devices that can isolate cell enriched fat grafts (also called nanofat or microfat) and stem cell fraction (SVF) from fat. Our pipeline products are FDA approvable stem cell therapies based on our technology for indications with unmet medical needs.
Please send cover letter and resume to firstname.lastname@example.org