Append medical, a growing medical device start-up in the field of the structural heart is looking for a QA manager to establish a quality system and support the company RA activity.
- Responsible for company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide
- Support the company RA activity
- Establish and manage a QMS in compliance with FDA-QSR, MDR & ISO13485
- Supporting R&D and manufacturing processes
- Responsible for writing/guiding employees for writing all company procedures, specifications, instructions etc.
- Periodic reports to Top management about Quality issues and analysis MRB, CAPA, ECOs, internal and external audits, product and process performance
- 3+ years QA experience in the medical device field
- A scientific degree
- Experience in supporting regulatory activities in US and Europe
- Experience in design control and manufacturing processes
- Experience in supplier quality management
- Excellent interpersonal skills
- Well organized
- High verbal and writing skills
- Fluent in English.
- Experience with structural heart related devices
- Experience with sterile devices and clean room
About Append Medical
Append Medical is a medical device start-up developing a system for reducing the risk of stroke in patients with non-valvular atrial fibrillation. Append’s system is designed to prevent blood clot leakage by achieving complete left atrium appendage (LAA) closure. Its unique design may allow it to mitigate device-related thromboembolism risk by leaving minimal foreign material at the closure site. The procedure itself is intended to be simple, fast and requiring less pre-procedure planning.
Please send relevant CVs to email@example.com