JO-2406-535910
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.
