Quality Assurance Engineer – 897433 MS

5 days left

Canton of Solothurn
18 May 2021
17 Jun 2021
Quality, GMP
Full Time
Contract Type
Experience Level

Quality Assurance Engineer – 897433 MS

Our client is a leading company in Switzerland. It is headquartered in Central Switzerland, Burgdorf and has another site in Solothurn. The Company has a global network of production sites, subsidiaries and marketing and sales partners. For our client, we are looking for a Quality Assurance Engineer. It is an initial contract with chances of extension or permanent headcount.

Main Responsibilities:

  • Participate in internal, customer and regulatory audits as well as supplier audits
  • Participate in general QM tasks, such as training, etc.
  • Participation in product management and project meetings to safeguard quality interests
  • Planning and implementation of the risk management process in development projects according to ISO 14971
  • Creation of risk analyzes
  • Support of the project and product management team in identifying measures to minimize risk
  • Ensuring the flow of information and communication within the company and with external customers
  • Training and methodical support for the project teams
  • Supervision and implementation of the daily tasks of Quality Assurance concerning production, especially releases, deviation reports, investigations, change management, quality documentation, coordination and processing of NCs and CAPAs.
  • Supervision and support of production and other areas / departments to ensure compliance with all relevant laws, regulations and specifications, such as cGMP and ISO 13485
  • Substitution of BRR (Batch Record Review)
  • Taking on special tasks and projects in consultation with supervisor
  • Reviewing and approving documents generated in development projects


Qualifications and Experience:

  • Professional experience in a GMP-regulated environment, preferably in the field of medical technology
  • Professional experience as a risk or quality manager
  • Very good knowledge of English & German
  • Completed studies at university / university of applied sciences with preferably technical or scientific background (IT, medical software advantageous)
  • Additional training in Q-Management or corresponding verifiable activity as QA
  • Familiar with risk management, Ishikawa and/or other tools
  • Familiar with the activity of standards interpretation in the relevant area
  • Familiarity with Microsoft Package, SAP, optimal DOORS, Azure

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