Description
Due to new Medical Devices Regulation requirement, we have a need for a quality assurance expert in medical devices area to take charge of a project related to technical development and manufacturing operations of assigned Medical Devices/Combination Products.Major Accountabilities:
Manage portfolio of assigned projects and 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 tasks 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.
Perform and 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.
Requirements:
Prior experience in quality assurance in medical devices products
scientific, technical and regulatory knowledge
Excellent knowledge of cGMP and medical device/ combination product regulations, standards and guidelines.
Good knowledge of medical device development and life-cycle management.
Good and proven ability to analyse and evaluate GMP compliance
Michael Bailey International is acting as an Employment Business in relation to this vacancy.