QA Medtech Engineer

vor 2 Wochen

Zürich, Zürich, Schweiz agap2 Switzerland Vollzeit

agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry.
We work in the Pharma, Medical Devices, Biotechnology, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant
, you will support our clients in the realization of their projects on site by bringing your expertise and skills.

You are agile and eager to adapt to different work environments, driven by the curiosity to discover what's behind the scenes of the most exciting projects in our clients' portfolios.

Main tasks:

  • Maintenance and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485 and MDR requirements
  • Preparation and support of product releases, including review of Device History Records (DHR) and batch documentation
  • Review and approval of validation documentation (plans, IQOQPQ protocols, reports) for processes, equipment, software, and cleaning
  • Management of changes, non-conformities, CAPA and complaints
  • Quality oversight of subcontractors and suppliers, including qualification and monitoring activities
  • Creation and update of standard operating procedures (SOPs) and work instructions

Your profile:

  • Engineering degree in production systems, mechanics, process or equivalent
  • Solid understanding of medical devices production and manufacturing processes (e.g., assembly, sterilization, packaging, labeling)
  • At least 3 years of experience with working knowledge in MDD/MDR and ISO13485
  • Strong communication skills with fluency in English and German (spoken and written mandatory)

Benefits:

  • Joining a group with strong development potential that aims to improve your employability on challenging and varied projects.
  • Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector.
  • Having a sustainable job with stability and access to a real collaboration.
  • Benefit from training with accredited and certified centers.
  • Having a local management team to support you in the achievement of your missions and in the development of your career.
  • Being part of a dynamic, committed team with real human values that we live by every day.

Thank you for your interest in this opportunity. Please note that only selected candidates will be contacted for an initial interview. In addition, only applications from Swiss and EU citizens can be considered. Unfortunately, due to Brexit, we are no longer able to accept applications from the UK.

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