Job Detail

Description:

 

Hutman Diagnostics AG is a start-up in vitro diagnostics company developing qualitative diagnostic tests for the detection and screening of multiple pathogens and antibiotic resistance markers of various infectious diseases.

 

We are looking for a constructive and solution-oriented personality as Senior Quality Engineer. As a start-up we are looking for a generalist who is willing and able to take over a broad range of tasks and responsibilities. This position will be for an unlimited period of time, starting as soon as possible. Location: Basel, Switzerland

 

The jobholder will report directly to the Head of Quality & Regulatory Affairs.

 

Responsibilities:

 

• Collaboration with development teams at Hutman and external partners.
  


• Quality review of development records from internal and external project teams.
  


• Supervise and drive processes owned by Quality, e.g. risk management, quality planning, verification & validation.
  


• Develop records and support others in developing records for the Technical File and the Medical Device File.
  


• Own or support owners of NCs and CAPAs.
  


• Support supplier development activities
  


• Perform supplier audits and internal audits
  


• Manage Quality owned processes, e.g. document & record control, NC, CAPA, internal & supplier auditing.
  


• Contribute to development and improvement of the QMS.
  


• Maintain Quality metrics and KPIs.
  

 

Additionally, in later stages of our project:

• Oversee manufacturing and quality control at suppliers.
  


• Product release.
  

 

Qualifications:

 

Education and experience

• University Degree in a natural science or in engineering.
  


• At least 10 years experience in quality engineering / quality assurance / supplier quality for development, manufacturing, and postmarket activities of medical devices, ideally for IVD devices.
  


• Used to work in global teams.
  


• Used to work with external development partners and suppliers.
  


• Proven success in influencing and in making risk-based decisions.
  


• Qualified auditor.
  


• Profound knowledge of relevant norms and regulations, and their application in practice.
  


• Experienced in developing efficient and effective procedures.
  


• Knowledge in applied statistics.
  

 

 

Soft Skills:

• A team player with assertiveness and strong communication skills who shows flexibility especially within a start-up company
  


• Leadership skills
  


• Systematic and analytical thinking
  


• Goal oriented, self-motivated, well organized, plans with foresight
  


• Fluent in English, spoken and in writing. German is a plus.
  


• Willingness to travel worldwide   

 

We offer:

 

Fast pacing environment with opportunities for development

Compensation commensurate for the position and responsibility

If you are interested in career opportunities with Hutman Diagnostics, please send us your CV and motivation  letter to hr@hutmandiagnostics.com.