QA Manager (M/F) - Medical Devices

View: 118

Update day: 24-04-2024

Location:

Category: Quality Assurance / Quality Control

Industry:

Job type: Full-time

Loading ...

Job content

Our client is developing a Class II.b Medical Devices and is based in Lausanne.

Responsibilities :

Being responsible for implementation, governance, performance reporting and maintenance of the QMS.
Ensure compliance to applicable regulatory requirements such as MDR, ISO 13485, US FDA, CFDA.
Work closely with R&D with development and maintenance of the technical files according to applicable regulatory requirements (e.g.: Risk Management as per ISO 14971 and Design Controls).
Coordinate with external stakeholders on matters relating to the quality system
Coordinate and conduct all audits (internal audits, suppliers audits)
Responsible for review and approval of internal investigations and CAPA
Elaborate and review changes to existing products, SOPs, test methods, process changes, design changes issues to define the requirements for regulatory submissions and notifications.
Manage compliance: maintain regulatory compliance of technical files and to all relevant regulations, rules and standards for products.

Profile :

Graduated with a master’s degree in life science, engineering or related fields.
At least 5 years’ experience as a Quality Assurance Engineer in a MedTech industry
Knowledge of regulatory affairs a real asset
Strong knowledge of FDA 21 CFR part 820, Medical Device Regulation (MDR 2017 / 745), ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11137, ISO 10993
Strong knowledge in flawless registrations of medical devices in USA and in Europe
Fluent in English. German or French is a plus.

Permanent Contract #boost

Loading ...

Click to apply for free candidate

Loading ...

Loading ...

Loading ...