Quality Specialist for Medical Devices

BaselTemporaryChemistry, Pharma, Biotech2019-02-14Bachelor / University of Applied Sciences
We are looking for a Quality Specialist with strong knowledge in Medical Devices for our client, a pharmaceutical company based in Basel area. This position is currently temporary until end of December 2019. If you are interested in this challenge, please, apply via e-mail, together with your latest CV. We look forward to your application.

Quality Specialist for Medical Devices

Your challenges

  • Manage portfolio of assigned projects, support a discipline and/or provide a service on his/her own or with a team of associates. Provide functional expertise in area of responsibility for medical devices and combination products.
  • Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools to ensure GMP compliance
  • Ensure that new products including web-based and mobile applications have been effectively and efficiently verified and validated prior to their release and that these designs meet effectively documented and implied user needs and requirements.
  • Improve the overall quality of mobile software, including peer reviews, software hazard analysis, requirements traceability, defect tracking, software metrics, configuration management and software tool validations
  • Ensure that software quality assurance efforts are lifecycle oriented during product requirements development and continuing throughout its lifetime
  • Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies
  • Release of medical devices for clinical studies and commercial use
  • Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients
  • Represent MD Quality in initiatives and cross-divisional projects
  • Lead project related activities in development of new tools and processes
  • Perform or support inspections and audits as required.
  • Provide support to BTDM line functions in GMP compliance related issues in area of expertise
  • Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
  • Meet internal and external guidelines regarding quality and safety
  • Support project management functions as a sub-team member in preparation for a Pre-Approval Inspection.
  • Contribute to internal compliance policy

Your skills

  • Degree in a scientific field. Medical device software background is a plus.
  • English fluent in speaking and writing, German and/or French desirable.
  • At least 3 years of industry experience.
  • Practical experience in IEC 62304, IEC 82304, ISO 14971, MDD/MDR, GDPR, 21 CFR part 820 / part 4 requirements and in Medical Mobile Applications

Your contact

Ms. Tanja Vrbanic, Recruitment Consultant, looks forward to answer your questions by phone +41 58 233 2100 or eMail.

You can apply directly online, or by eMail. Please mention reference in your application