Senior Quality Expert / Compliance Lead , MedTech (897394-MS)

Canton of Basel-Stadt (CH)
27 Apr 2021
27 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel Pharma therapies & Combination Products. Company is currently developing several digital connected devices to therapies in oncology, neurology, ophthalmology etc  and Software as Medical Devices.

We are currently looking for a Quality Expert for Medical Device Software department group within our Client company to be based in Basel. It is an initial contract role with high chances of extension Basel.

Purpose: The Quality Expert Medical Device Software will support the review and maintenance of assigned processes of the Quality Management System and will as well support the development and commercialization of assigned Medical Device Software Projects are conducted in accordance with Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency.

Main Responsibilities:

  • 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 device software.
  • Ensure that new medical device software products including web-based and mobile applications are developed, commercialized and maintained through its lifetime in compliance with medical device, software and data security regulations and standards.
  • Write, review and approve deliverables (e.g. procedures, records, device documentation) and related tools (e.g. IT, document systems, training tools) to ensure compliance to medical device and software regulations and standards
  • Provide QA functional expertise in the review of quality management system processes for compliance to regulations, standards and guidelines related to Medical Device Software.
  • Improve the overall quality of medical device software, tools and procedures, including peer reviews.
  • Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
  • Represent Medical Device Quality in initiatives and cross-divisional projects.
  • Support inspections and audits as required.
  • 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, safety and security (quality manuals, regulatory cGMP guidelines, health authority requirements, international standards, SOPs, Health, Safety and Environment/HSEs, etc).
  • Promote and enforce compliance to guidelines.
  • Support project management functions as a sub-team member in preparation for a Inspection.
  • Write/contribute to internal compliance policy and/or comment to regulations. Ensures interfaces and interoperability at solution level aligned with Ecosystem Operations System Engineering, DHF strategy, and QMS.

Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Education: Graduate in a scientific field. Medical device software background.
  • Languages: English fluent in speaking / writing, German and/or French desirable.
  • At least 5 years of relevant experience in Medtech or combination products
  • Practical experience in managing projects in compliance with ISO 13485, 21 CFR part 820 / part 4, IEC 62304, IEC 82304, ISO 14971, IEC 62366, MDD/MDR, GDPR and other relevant standards and guidances related to medical device software.
  • Ability to influence people, negotiate and communicate.
  • Sound scientific, technical and regulatory knowledge in a specific area.
  • Excellent knowledge of cGMP, working knowledge of medical device software regulations, standards and guidelines.
  • Good knowledge of medical device software development and life-cycle management.
  • Good organizational skills.
  • Good and proven ability to analyze and evaluate GMP compliance.
  • Ability to work in cross-functional teams including Quality, Technical Development , Regulatory, Human Factors, Risk Management, IT and other functions