Q.A manager

Company Background:

BeWeld Medical specialize in the development of a cutting-edge manufacturing process for tissue welding. Our technology has found applications in the heart valve graft market, where we've developed state-of-the-art transcatheter aortic valves.  

Job description:

We are in search of a Quality Assurance manager  to lead and oversee all quality assurance activity within BeWeld with emphasis on the company’s valves manufacturing floor.

Responsibilities:

Establishment and implementation of QMS in accordance with ISO 13485:2016

• Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements. (ISO 13485/MDR/CFR21/MDSAP)
• Managing the Quality assurance on the manufacturing floor
• Suppliers’ qualification and evaluation
• Writing quality procedures
• Management of trainings and adequate competency within the company
• Management of documentation control, DHF, DMR and DHRs
• Responsible for the management and performance of the QMS, including continuous improvement, quality management reviews, change control, complaints, Deviation management, supplier evaluation, investigation and CAPA, self-inspection and generation of quality agreements.
• Management and handling of the clean room activities; monitoring, ISO 7 validation and control activities

Requirements:

• Bachelor’s Degree in science or mechanical / medical engineering or similar
• At least three years’ experience in leading QMS activities in a medical device company
• Fluent English
• Good writing skills
• At least 6 years of experience in a medical device quality assurance role.
• Must have basic knowledge of manufacturing processes.
• Ability to work on your own initiative with minimum direction.
• Ability to organize information effectively, prioritizing tasks according to their urgency and importance.
• Proficient use of Microsoft applications – such as Word, Excel, PowerPoint
• Quality qualification (lead auditor, etc.) and training
• Team player, working side by side with R&D and production teams