Quality Assurance Engineer – 897433 MS

5 days left

Location
Canton of Solothurn
Salary
Competitive
Posted
18 May 2021
Closes
17 Jun 2021
Discipline
Quality, GMP
Hours
Full Time
Contract Type
Contract
Experience Level
Graduate

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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