Quality & Regulatory Affairs | Medical Devices
Há 10 horas
(Manufacturing Environment | MDR | ISO 13485)
At
Ultra Controlo
, we develop engineering solutions for medicinal and industrial gases with a direct impact on safety in hospitals and industrial facilities.
We are looking to strengthen our team with a
Quality & Regulatory Affairs
profile, with strong involvement in the manufacturing floor and in the regulatory requirements applicable to
Medical Devices
.
If you work (or want to work) across
Quality Management Systems, production, audits and MDR technical documentation
, this project may be for you.
Your role
- Implement, maintain and continuously improve the
Quality Management System
in a manufacturing environment (
ISO 9001, ISO 13485, ISO and HTM 02-01
), ensuring compliance with applicable regulatory requirements, namely the
MDR (EU 2017/745) - Prepare and maintain
MDR technical documentation (technical files) - Support certification processes and regulatory compliance activities
- Work closely with
Production, Engineering and Purchasing
on quality-related topics - Participate in
internal and external audits
, non-conformity management and
CAPA - Ensure
traceability, document control and continuous improvement
What we value
- Experience in
Quality within an industrial/manufacturing environment - Hands-on experience with
ISO 13485
and
MDR technical documentation - Solid knowledge of
ISO 9001 - Knowledge of or exposure to
ISO and/or HTM 02-01 - Interest in the
Medical Devices
field - Detail-oriented, autonomous and rigorous profile
- Technical English
(mandatory)
What we offer
- A technically solid project with real impact
- Professional growth in a highly specialized field
- Stability, continuous training and international exposure
In short, this role is for you if you:
- Have hands-on experience in
Quality within a manufacturing environment - Work with
ISO 13485
(and have exposure to
ISO 9001
) - Have dealt directly with
MDR technical documentation - Are looking for a
hands-on role
in
Medical Devices
Applications
Send your CV to
-
Subject:
Quality & Regulatory Affairs
-
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