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Quality Manager

2 weeks ago

Wicklow, Ireland Cpl Full time

JO--

NEW ROLE : Quality Manager required for plastics contract manufacturing facility in Wicklow. Working with medical device clients in the US, this is a customer facing role and will be responsible for audits, managing QMS and customer complaints. Knowledge of knowledge of ISO, ISO and cGMP essential.

Responsibilities 

· 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.

· Formalise 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.

Requirements:

Min 5years Quality management experience with evidence of building strong relationships. Evidence of working knowledge of Lean / Continuous improvement / WCM. Evidence of working knowledge of ISO, ISO and cGMP. Experienced in QMS auditing to ISO 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.