Quality Assurance Manager
ICDS Recruitment
Offaly
Quality Assurance Manager - Tullamore. Our medical device client is looking for the ideal candidate to be responsible for the management, direction and coordination of all quality and regulatory activities for the site. Responsibilities: Ensure department targets and objectives are met – s afety, quality, , complaint analysis, product conformances ; Ensure achievement of recognised quality standards (ISO/FDA) and legal compliance. Provide leadership on regulatory topics and application of standards. Audit contractors and suppliers. Provide advice and support to sales/ technical personnel and other stakeholders. Monitor quality data daily, and take appropriate action, make decisions or highlight when necessary. Lead all elements of Quality Control, document control, validation, calibrations, customer Quality interface and supplier Quality assurance by developing key supplier partnerships. Develop and deliver excellence in manufacturing practices and work with team to develop engagement of all employees in the improvement of Quality, creating training and quality standards to enhance and ensure competence; Management of the Quality Department including annual goal setting, multiskilling, training and management of Quality standards; Any other duty assigned within the skill of the employee. Requirements: Bachelor’s degree in Quality/Science/Engineering or similar. 10 years of manufacturing experience working in a quality assurance role or related department desired. Experience with statistical analysis, DOE, Pareto charts and histograms . Desirable: Medical Device background with FDA/ISO or have substantial experience with ISO 9001/13485 will have an advantage. Thorough knowledge and understanding of manufacturing systems and solid working knowledge of processes and products. Well versed in statistics, detail oriented / able to interpret data. SAP experience preferred. Statistical software experience preferred. Lean Six Sigma Green Belt Certification or a willingness to gain such certification is desirable. This job originally appeared on RecruitIreland.com.
2326 days ago