Quality & Regulatory Affairs | Medical Devices

Há 10 horas


Queluz, Lisboa, Portugal Ultra Controlo Tempo inteiro

(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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