Job Title: Quality Assurance Manager
We are seeking a highly skilled and experienced Quality Assurance Manager to join our organization. The successful candidate will be responsible for leading the Quality Control Laboratory, ensuring compliance with regulatory requirements and company policies.
Main Responsibilities:
* Leadership Role: Prepare and implement plans both long and short term for your area of responsibility in line with the company's defined strategy and agreed financial targets.
* Maintaining Accreditation: Manage the Quality Management Systems and SOPs for the laboratory, ensuring the requirements of ISO 17025 are implemented, maintained and complied with.
* Laboratory Planning: Manage Quality Control Laboratory work planning to ensure all samples are tested in a timely fashion.
* Scheduling and Supervision: Schedule, coordinate and supervise all testing within the QC laboratory, ensuring that all testing is carried out in a timely fashion to meet company objectives and relevant KPIs.
* Team Development: Supervise and develop the core QC Lab team by mentoring, training, and supporting personnel development plans, including allocate daily tasks for all QC lab personnel, staff issues, allocation of holidays, delegation of extended working hours when required, and in conjunction with company management policy and requirements.
Key Skills and Qualifications:
* Third Level Qualification in Engineering/Science.
* Five to eight years of experience in regulated manufacturing – medical device, pharma, biotechnology, life science.
* Five to eight years plus in a QC laboratory environment.
* Two to five years of management or supervisor experience.
* Working knowledge of ISO 17025.
* Working knowledge of IVDD 98/79/EC and/or IVDR (EU) 2017/746.