Quality Expert for Medical Devices(Combination Products)
Only English-written CV will be accepted
For our client in Basel, we are looking for Quality Expert for Medical Devices (Combination Product), for a 10 months contract.
Duration: ASAP to 31/12/2018
The Quality Expert Medical Device has to ensure technical development and manufacturing operations of assigned Medical Devices/Combination Products are conducted in accordance with Company's 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.
- 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 (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).
- 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.
- 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.
- Lead and support direct reports in line with Novartis values and behaviour including objectives setting, performance evaluations, development planning and participate in recruiting process.
- or another related science
- English fluent in speaking / writing,
- German and/or French desirable
- At least 3 years of experience with focus on Combination Products (21 CFR 3.2(e)).
- Experience in Design Control
- Experience with Technical Documentation for Combination Products.
- Good and proven ability to analyse and evaluate GMP compliance.
- 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.
- Ability to influence people, negotiate and communicate.
For further details please contact Aleksandra Sztajerowska:
Harvey Nash AG
+41 44 296 8844