Quality Operations Manager Galway Medical Devices

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Your responsibilities:

*Health and Safety - focus in line with plant objectives to ensure initiatives are successful and agreed targets are achieved.

*Develop Quality Operations Strategy for the business unit.

*Drive a Quality continuous improvement and innovation culture.

*Develop strong links with customer organisations.

*Ensure compliance to the Quality Management system in all activities.

*Participate in new product introductions to ensure quality is built into all products early in their life cycle.

*Management and continued development of Quality staff.

*Promote awareness of the applicable regulatory requirements and Quality Management system requirements throughout the organisation.

*Support regulatory agency and customer Quality audits.

*Ensure all aspects of the site QMS are managed and developed in line with regulatory standards, and ensure a culture of continuous improvement is in place to drive improved effectiveness and efficiency.

*Authority to place products or processes on hold.

*Design and develop forms and instructions for recording, evaluating, and reporting quality data.

*Manage Corrective and Preventive Actions.

*Drive the utilization of formal problem-solving techniques to resolve process-related issues.

*As required, lead cross-functional teams to support resolution of product and/or process-related issues or objectives.

*Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standards.

What your background should look like:

*Level 8 degree in Science, Engineering or related subject.

*5+ years relevant Supplier Quality / Quality Operations experience in GMP Manufacturing environment in Medical Device/Pharma industry

*Ability to work as a team member.

*Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.

*Good organization and investigation skills are required.

*Excellent communication skills. To apply for this role today please submit an up-to-date CV or get in touch with Cathy Byrne at Real Staffing.

To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales