Quality Systems / Quality Compliance Man

Collins Mcnicholas Recruitment

Sligo

Quality Systems / Quality Compliance Manager. The primary function of the Quality Systems / Quality Compliance Manager will be to; Implement and ensure Quality System Compliance according to ISO 13485. Set direction and identify priorities of the Compliance to regulatory requirements. Responsibilities. Reporting to Plant Manager, you will be responsible for: Leadership Implement and ensures compliance to the quality requirements set in ISO 13485, GMP and corporate quality system. Lead site personnel in the maintenance of compliance levels according to ISO13485. Leads the Documentation Control and Change Control processes. Leads Regulatory Affairs. Provide leadership and guidance in the implementation of regulatory strategies and plans to ensure currency of device Technical files and Design Dossiers. Lead the Validation process. Leads the Management Review process. Leads the internal audit and supplier quality processes. Leads the Sterilization process. Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations. Set direction and identify priorities of the compliance requirements. Assign resources and responsibilities. Provide leadership and development of the organization to maximize effectiveness and assist development of employees of the Compliance and validation functions. Review & Evaluation Implement and ensure compliance to the quality requirements per the site, GMP and corporate quality system ensuring all procedures and policies are up to date. Integrates corporate requirements and promotes synergy/consistency with other sites. Ensures a proactive evaluation of regulatory, compliance and quality issues and integrates them into the QMS on a priority basis. Project Management Responsible for leading continuous improvement projects including creation, scoping and implementation. Participate as a key member of the departmental staff team contributing to the overall effectiveness of the business. Project manage and schedule key projects and initiatives ensuring timely execution and goal achievement. Implementation of lean manufacturing philosophy and six sigma principles to eliminate waste. Communication Represents company on corporate wide initiatives and teams as requested. Report pre-defined KPI’s on a weekly basis and assist in developing the quality metrics. Demonstrates through management style respect for the core values and a commitment to teamwork and communication. Training Trains employees on areas of expertise. Develop the skills of the employees of the department, ensuring they are trained in all duties required. Develop staff on new quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site. Requirements. A level 8 Degree in a Quality, Science or Engineering discipline. Excellent working knowledge of Quality System Requirements such as ISO 13485, MDSAP and 21 CFR 820. 5 – 8 year’s experience working in the Quality Department of a Medical Device/Pharmaceutical or Healthcare company. An understanding of SAP is an advantage. Organized with a proven ability to achieve targets. For a confidential discussion and more information on the role, please contact Davin Ferguson on 071-9140251 or email davin.ferguson@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on RecruitIreland.com.

1830 days ago