Our client, a leading Medical device company based in Wicklow, is hiring a Quality Manager.
Responsibilities 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.
* Implement 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 root 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.
Requirements
* 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 the wider team.
This is a fantastic opportunity to join a forward-thinking team and thrive in a collaborative, supportive environment that values creativity and teamwork!
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