Quality Systems Manager

CAREERWISE RECRUITMENT

GALWAY

A Quality Systems Manager is required by CareerWise Recruitment for our Galway based client. Reporting to the Quality Director, the Quality Systems Manger will be responsibility for maintaining and driving continuous improvement of the Plants Quality System. The Quality Systems Manager is responsible for the administration, supervision, and development of the Galway Quality Systems functions. This position is responsible for ensuring full procedural compliance to the regulatory requirements of 21 CFR 820, ISO13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD)R sch3 and other applicable regulations. Please contact Tom Devaney for more information. THE ROLE: * Ensuring that the quality system requirements are effectively established and effectively maintained in accordance with FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3, MDR and any other applicable regulations. * Report on the performance of the Quality System to Plant Management. * Promote awareness of the applicable regulatory requirements and quality management system requirements throughout the organisation. * Ensure compliance to the MSDAP Program. * Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: - Delivery of raw materials and components. - Manufactured devices and equipment. - Documentation associated with these functions. * Develop, track, and report on the following administrative systems: - Department metrics. - Department objectives. - Personnel development and training. * Support regulatory agency and customer quality audits. Act on behalf of Plant Management during 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 (this includes areas such as Document Control, Deviations, Complaints etc. * Responsible for Quality audit function. * Responsible for Document Control function. * Responsible for Training administration. * Responsible for Customer Complaint Management. * 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 Action program. * Utilize 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. REQUIREMENTS: * Bachelors 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1394 days ago