Regional Quality Operations Manager

COLLINS MCNICHOLAS RECRUITMENT

OFFALY

My client, a leading US multinational, is looking to hire a Regional Quality Operations Manager . It is a 12-month fixed term contract and based on their site in Offaly . The ideal candidate will have strong people management experience and have experience in a similar senior quality role. Responsibilities: (full job description available on request) Responsible for providing leadership and direction to the Quality Operations Managers and staff within their assigned facility/facilities as well as other facilities as assigned. Responsible for ensuring product release is executed as per approved work instructions. Ensure the Operational Quality activities are consistent with the goals and objectives of the organization. Lead by coaching, managing, and monitoring staff through ongoing performance feedback and formal reviews, as well as demonstrating best practices in job function and development initiatives which target individual strengths and weaknesses. Ensure that the required initial and continuing training of Quality Operations personnel is implemented. Support the implementation of quality system standards through providing direction to quality team. Monitor facility non-conformances, customer complaints and audit findings from internal and external audits. Perform periodic audits within the assigned facility and participate in other facilities as needed to support continuous monitoring of the quality system. Lead or assist in customer and notified body quality/regulatory audits at their facilities. Collaborate with operations management within their assigned facility/facilities to develop sustainable remediation action plans. Actively participate in assigned facility projects alongside the Operations Management team to identify opportunities for improvement and efficiency all while ensuring the spirit of the regulations that govern the business are never compromised. Apply regulatory knowledge and judgment to the evaluation of quality concerns as well as regulatory compliance issues. Responsible for leading support during Regulatory inspections process on-site at facilities. Support the continuous improvement efforts within the facility by participating in quality and performance improvement projects. Monitor Operational Quality facility expenses to ensure actual expenses are managed with the plan and the subsequent forecasts by quarter. Support a safe, clean and secure working environment by supporting procedures, rules and regulations; supports plant safety committees that evaluate plant machinery, equipment and working conditions. Requirements: Bachelor’s Degree in scientific, engineering, clinical or regulatory course of relevance. Professional Certification (Professional certifications and regulatory training certificates in relevant disciplines are desirable.) Must have working knowledge of regulations and standards, including, but not limited to, U.S. FDA device QSR and cGMP regulations, EU medical device and Pharma requirements, Canadian device and drug compliance requirements and ISO 13485 medical device standard. Must have strong people management and leadership experience. Minimum of 3 years of experience in a similar senior management role. Willingness to demonstrate through daily activities a model of continuous monitoring of quality system activities to ensure compliance to documented standards. Demonstrated organizational, project management, time management and problem-solving skills. Demonstrated ability to analyze data and performance metrics. For a confidential discussion and more information on the role, please contact Niamh Cregg. 071-9149732. niamh.cregg@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1372 days ago