Quality Assurance Manager

Beschreibung

New opportunity has opened up with a global client, based in Switzerland in the quality assurance department for medical devices. This role is offered on initial 6 months contract with possibility for extension

This position will be responsible for ensuring the compliance and quality of technical development and manufacturing operations of assigned Medical Devices/Combination Products.

Your daily tasks:

• 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. * Lead project related activities (e.g. 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. * 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.

Requirements:

Degree in life science discipline

scientific, technical and regulatory knowledge and experience related to medical devices/combination devices Excellent knowledge of cGMP, quality assurance, manufacturing and auditing processes Good knowledge of medical device development and life-cycle management. Good organizational skills. Good and proven ability to analyse and evaluate GMP compliance.

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.