Q.A manager - BeWeld Medical

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

o Develop and maintain an effective and robust quality system which complies with all

relevant regulatory requirements. (ISO 13485/MDR/CFR21/MDSAP)

o Managing the Quality assurance on the manufacturing floor

o Suppliers’ qualification and evaluation

o Writing quality procedures

o Management of trainings and adequate competency within the company

o Management of documentation control, DHF, DMR and DHRs

o 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.

o Management and handling of the clean room activities; monitoring, ISO 7 validation and

control activities

Requirments:

o Bachelor’s Degree in science or mechanical / medical engineering or similar

o At least three years’ experience in leading QMS activities in a medical device

company

o Fluent English

o Good writing skills

o At least 5 years of experience in a medical device quality assurance role.

o Must have basic knowledge of manufacturing processes.

o Ability to work on your own initiative with minimum direction.

o Ability to organize information effectively, prioritizing tasks according to their

urgency and importance.

o Proficient use of Microsoft applications – such as Word, Excel, PowerPoint

o Quality qualification (lead auditor, etc.) and training

o Team player, working side by side with R&D and production teams