Beschreibung
For our client in Basel (Switzerland) we are looking for a Quality Expert for Medical Mobile Applications for a 1 year contract.
Location: Basel
Duration:
Workload: 100%
Background:
The Quality Expert has to ensure technical development and manufacturing operations of assigned Medical Devices/Combination Products are conducted in accordance with Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency.
Tasks & 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 devices and combination products.
. Write, Review and approve deliverables (eg procedures, records, third party work, contractors, clinical trial material, components) and related tools (eg IT, document systems, training tools, facility validation) to ensure GMP compliance.
. Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting.
. 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 (eg development of new tools, processes).
. Perform or support inspections and audits as required.
. Coach and develop people; participate in recruitment of talent. 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 (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.). Promote and enforce compliance to guidelines. If managing associates, ensure same for them.
Requirements:
. At least 3 years of relevant 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.
. Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines.
. Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
. Good knowledge of medical device development and life cycle management.
. Fluent English. German and French is an asset
For further details please contact Mateusz Czarnocki.