Our client, a leading Medical device company based in Wicklow is hiring a Quality ManagerResponsibilities include but are not limited to the following:Manage and develop quality assurance systems as an adjunct to production led quality control for internal and external manufacturing.Ensure robust systems are in place to maintain compliance with customer specifications, the quality management system and best practice.Continue to develop and maintain quality standards for the business in line with ISO certification and best practice.Formalize and document all quality training and standards, provide and supervise all quality related training and drive strict adherence to these quality standards.Implementing and execute inspection, testing, and evaluation methods to ensure that products and materials adhere fully to these standards. Develop and regularly report to relevant KPIs to confirm adherence.Maintain an effective internal auditing system per the QMS requirements.Continue to develop and maintain route cause analysis and timely and appropriate permanent corrective action in any case of non-adherence to standard.Roster all quality staff according to production plan requirements and sign off on and expedite fortnightly payroll data for quality personnel to payroll processor in a timely manner. Ensure quality team are agile to manage changing customer requirements.Drive a continuous improvement ethos within the Quality department.Recruit all staff for quality positions with the assistance and involvement of HR.Implement and maintain a performance review process for all direct reports to include performance appraisal, retention and training. Identify any skill gaps and implement training to bridge such gaps.Liaise effectively and continuously with all other departments to effectively communicate the required quality standards and ensure strict adherence to these standards.Liaise directly with customers as a primary point of contact in QA.Lead investigation of customer complaints, implementing corrective and preventative actions in a timely manner and align with customer requirements.Provide oversight of external manufacturing by implementing and maintaining effective supplier quality measures.Preferred 5-10 years Quality management experience with evidence of building strong relationships.Evidence of working knowledge of Lean / Continuous improvement / WCM.Evidence of working knowledge of ISO9001, ISO 13485 and cGMP.Experienced in QMS auditing to ISO 13485 or supporting on-site customer audits.In-depth knowledge of process validation.Strong attention to detail.Strong organizational skills.Ability to communicate complex quality related matters to wider team.A team playerThis is a fantastic opportunity to join a forward-thinking team and thrive in a collaborative, supportive environment that values creativity and teamwork!Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.-Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce-