Quality Manager

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

JO

NEW ROLE : Quality Manager required for medical device manufacturing facility in Wicklow. Reporting to the MD on-site, the successful candidate will sit on the senior leadership team. Working with 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 ISO9001, ISO 13485 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 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.

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