QA/RA Engineer

Nordrhein-Westfalen  ‐ Vor Ort
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
Sie finden vakante Projekte hier in unserer Projektbörse.

Beschreibung

Quality and Regulatory Design Engineer
Dusseldorf
6 Month Contract
€70 per hour

Optimus Life Sciences is currently in partnership with a leading Medical Device company in Germany looking to recruit an experienced Quality and Regulatory specialist at their site near Dusseldorf.

The job requires a background in engineering, as well as hands-on experience in the medical device industry. Knowledge of the current and upcoming medical device regulations is a must. Experience implementing this knowledge within a previous position will be a massive advantage.

Responsibilities

  • Overall responsibility for ensuring the adequacy of design quality, including documentation and other supporting quality evidence.
  • Facilitating and managing Design and Process in a research and development setting
  • Providing guidance and oversight of the plans and methods for subsystem verification.
  • Providing guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices. Providing oversight and approval for Reliability Plans and ensure that they are properly executed throughout the development and qualification processes.
  • Participating in engineering Design Reviews
  • Participating in Defect/Issue Management and Change Control Boards, as appropriate.
  • Managing the Risk Management Process per ISO 14971
  • Developing Quality inspection procedures, including sampling plans, for both production level components and finished devices.
  • Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions.
  • Contributing to the development of Process Flows, Control Plans, Design of Experiments, Measurement Systems Analyses, and Process Capability Analyses.
  • Ensuring all FDA and ISO validation requirements are met and for the review and approval of all validation protocols (IQ, OQ and PQ)
  • Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
  • Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative products.
  • Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.

Requirements

  • 5+ years of experience of developing complex electro-mechanical in a regulated industry
  • Knowledge of Standards Applicable to Medical Device Safety/Risk Management (ISO 13485, ISO 14971, ISO 62303, IEC , US 21 CFR Part 820, and related standards)
  • Experienced in the practical application of Systems Engineering and Systems Verification principles
  • Knowledge of Design Control Systems and ability to apply project management techniques
  • Experience with supplier management and component qualification practices
  • Experience managing a comprehensive risk management process for complex medical devices
  • Strong leadership skills with the ability to influence without direct authority
  • Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).

If you're interested in applying for this role, please send a CV to (see below) for more detail - thanks!

Start
keine Angabe
Von
Optimus Search
Eingestellt
11.07.2018
Projekt-ID:
1596203
Vertragsart
Freiberuflich
Um sich auf dieses Projekt zu bewerben müssen Sie sich einloggen.
Registrieren