For our customer located in Basel/Switzerland we are currently looking for (m/f) an QA / QC Expert
- Type of placement: 12 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
The Quality Expert Medical Device 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.
- 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 (e.g. IT, document systems, training tools, facility validation) 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 (e.g. development of new tools, processes).
- Perform or support inspections and audits as required.
- Provide support to BTDM line functions in GMP compliance related issues in area of expertise (e.g. Medical Device standards).
- 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.
- Support project management functions as a sub-team member in preparation for a Pre-Approval Inspection.
- Write/contribute to internal compliance policy and/or comment to regulations.
- Education: Graduate in a scientific field. Medical device software background is a plus.
- Languages: English fluent in speaking / writing, German and/or French desirable.
- 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.
- 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 and combination product regulations, standards and guidelines.
- Good knowledge of medical device development and life-cycle management.
- Good organizational skills.
- Good and proven ability to analyse and evaluate GMP compliance
Kindly be informed that this job offer is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.
Please attach your CV in Word format.
SimplyVision is looking forward to your application.