Assistant Quality Manager - Med Dev
Brightwater
Sligo, Mayo
A growing Medical Device company in the West requires an experienced quality professional to provide Quality leadership to it`s business. This is an exciting opportunity to lead a business are within their manufacturing operations. A senior salary and benefits package is on offer for the right candidate. RESPONSIBILTIES. • Lead and develop the Quality Team. • Develop and advise on the continued development of quality systems and procedures for the business, including the development of product specifications / drawings / quality plans in conjunction with NPC personnel and the development of Master Validation Plans as required. • Provide leadership in change management and risk assessment, specifically process risk and capability analyses. • Conduct, lead, or direct product complaint investigations. • Coordinate the Corrective and Preventive Action (CAPA) program. • Participate in the Internal audit program. • Provide project leadership for implementing continuous improvement projects. • Provide leadership and resources for verification and release of finished goods into distribution. • Ensure Quality team is trained to FDA QSR and ISO 13485 / 14971 requirements. ESSENTIAL FUNCTIONS OF THE ROLE. • Personnel Staffing and Management. • Problem Solving and Analyzing. • Project Managing (includes AFE process. • Fiscal Managing (includes budget preparation. • Goal Setting. • Communicating/Leading. • Processes Improvement. QUALIFICATIONS. Degree in Physical Science, Engineering, or other related discipline. 10 years experience in a quality engineering/systems role including people management experience. • Knowledge of applicable foreign and domestic regulations. • Knowledge of quality engineering tools and statistical quality control techniques. • Knowledge of quality auditing techniques. • Knowledge of process validation techniques. • Knowledge of project management skills. • Basic knowledge of sterilization. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2555 days ago