10 days ago

Medical Device Technical Expert - QA Operations

Harvey Nash AG

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Medical Device Technical Expert - QA Operations

Harvey Nash is looking for a Medical Device Technical Expert - QA Operations for a 14 + month project in Switzerland.

The Quality Expert Medical Device has to ensure technical development and manufacturing operations of assigned Medical Devices/Combination Products are conducted in accordance with Novartis Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency.

You are responsible for

* Managing portfolio of assigned projects, supporting a discipline and/or providing a service on his/her own or with a team of associates; Providing functional expertise in area of responsibility for medical devices and combination products.

* Writing, Reviewing and approving 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.

* monitoring, analysis and reporting of GMP related KPIs as part of management reporting.

* Managing quality problems and technical matters and ensuring they are resolved consistently and in accordance with global standards and policies.

* Releasing of medical devices for clinical studies and commercial use.

* Supporting Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.

* Representing MD Quality in initiatives and cross-divisional projects.

* Leading project related activities (e.g. development of new tools, processes).

* Performing or supporting inspections and audits as required.

* Providing support to BTDM line functions in GMP compliance related issues in area of expertise (e.g. Medical Device standards).

* Coaching and developing people; participating in recruitment of talent. Supporting a culture of high performance and trust. Assuring that the required level of knowledge and skills is available and identify competency gaps. Establishing and implement training and development plans.

* Meeting internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.). Promoting and enforcing compliance to guidelines. If managing associates, ensure same for them.

* Supporting project management functions as a sub-team member in preparation for a Pre-Approval Inspection.

* Writing/contributing to internal compliance policy and/or comment to regulations.

* Leading and supporting direct reports in line with clients' values and behaviour including objectives setting, performance evaluations, development planning and participate in recruiting process. Requirements

* University degree in a relevant subject

* Work experience in the pharmaceutical or medical device industry

* Experience in planning and writing technical documentation for Medical Devices and combination Products

* ISO 13485, ISO14971, MDD and QMS for Medical Devices

* Experience with Medical Device Design Control

* Ideally experience in the field of Auto-Injectors and Safety Devices

* Excellent communication skills in German and English

* Excellent Project Management skills

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to beata.arciszewska@harveynash.com. For further details feel free to call me +41435088640. I am looking forward to receiving your application.

Harvey Nash AG
Beata Arciszewska
+41 44 296 8844