Quality Manager Medical Devices
A leading Medical Device company in Cork is seeking an experienced Quality Manager to lead its Quality team at its highly regulated manufacturing site. You will be responsible for leading and managing a Quality Team in supporting site day to day operations. You will promote an awareness of Quality Assurance throughout the business and ensure Quality Systems are maintained and developed in line with the site Quality Plan and Global Symmetry objectives. About the Job: Liaise with and support all functions in managing Customer requirements and Change initiatives. Providing Manufacturing Support and leadership to QA and Engineering teams, applying practical problem solving techniques as required. Provide Leadership regarding Continuous Process Improvement of the QMS and Operational Processes, with a Quality and risk management perspective. Manage all External Audits ( Customer and Regulatory agencies ) ensuring all QMS requirements per FDA Part 820 and ISO 13485 are robust and compliant. Maintain a culture of compliance to QMS systems throughout the organisation including:- A compliant and timely NC / CAPA system, Change Control system, Auditing system, Validation system, Supplier Management, Records Management, DHR and DMR systems. Ensure appropriate Risk Management systems are applied with regard to NC and Change Management. Ensure best practice Processes and Equipment Validation is conducted at all times. About You: A bachelor’s degree in engineering or a related field and/or a combination of practical and educational experience in the medical device industry is required. The ideal candidate will have worked and thrived in the current medical device industry with the majority of their experience gained during the last 5 years. The ability to complete the tasks above on his/her own initiative is paramount. Superior communication skills are essential to deal with a growing and diverse workforce and customer base. Experience in managing a team of resources. Experience Leading External Audits by Regulatory Bodies. Experience in leading FDA audit preparation and management. Have thorough working knowledge and comprehensive understanding of ISO13485:2003 and 21 CFR Part 820. Possess the drive and ability to drive systems and compliance throughout the organization. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
193 days ago