Quality Engineer

Vor 4 Tagen

Berlin, Berlin, Deutschland Meet Life Sciences Vollzeit

An established
international medical device manufacturer
is looking to appoint a
Quality Engineer
to support product development and lifecycle activities within a regulated environment.

This role sits at the intersection of
Quality, R&D, and Regulatory Affairs.

The Role

You will be responsible for reviewing, maintaining, and improving
technical documentation
to ensure compliance with
EU MDR
and a
hardware and software medical device projects
.

Key Responsibilities

  • Review and assess technical documentation including:
  • Design dossiers and design controls
  • Risk management files
  • Verification and validation documentation
  • Process and equipment validation
  • Biocompatibility, clinical evaluation, and post-market surveillance
  • Ensure compliance with
    EU MDR (2017/745)
    to stand against
    ISO 13485, ISO 14971, IEC 62366, IEC 62304, ISO 10993
  • Evaluate documentation for clarity, consistency, and audit readiness for external reviewers
  • Support creation and maintenance of quality and technical documentation (labelling, inspection forms, validation plans)
  • Maintain documentation throughout the full
    product lifecycle
  • Participate in
    internal and external audits
  • Support responses to notified body and authority questions
  • Coordinate and support
    change management
    activities and Change Board meetings
  • Work closely with
    R&D, Regulatory Affairs, Production, and Product Management

Your Background

  • Bachelor's degree in
    Biomedical Engineering
    ,
    Life Sciences
    , or a related field
  • Several years of experience in
    medical device quality, engineering, or technical documentation
  • Strong knowledge of
    ISO 13485
    and
    EU MDR
  • Experience with additional standards and regulations is an advantage
  • Structured, detail-oriented, and comfortable managing multiple priorities

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