Nordson MEDICAL, a global leader in the medical device industry, is seeking an experienced and highly motivated Quality Technician to join our team in Galway.
We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.
Summary of the roleAs a Quality Technician you have the responsibility for the effectiveness of assigned areas of the company's quality system.
Provides support to the operations function.
Maintain records in accordance with the quality system requirements, which show that products manufactured by Nordson meet the requirements of end users, customers, regulatory authorities and the company.
Maintain assigned areas of the Nordson Medical quality system in accordance with the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations (if applicable) Role and ResponsibilitiesGeneral DutiesProvides support to Manufacturing and Product Engineering and Quality Engineers for commercial/validation projects.
Supports implementation and maintenance of manufacturing methods, processes and operations for new and existing products.
Supports dispositions of nonconforming material and processes.
Supports sustaining Engineering and QE in resolving Manufacturing issues in the plant.
Participate in lean and cost reduction activities.
Supports the conduct of investigations and associated actions related to CAPA and Internal/external audit activities.
Supports investigations and associated actions related to customer complaints.
May assist designated auditors in the performance of site internal audits.
May support execution/hosting of external auditsSupports maintenance of Quality System implementation.
Specific Duties and ResponsibilitiesReview batch records and approve release of product.
Provide accurate Certificates of Conformance and/or Certificates of Analysis.
Effectively communicate with other staff, customers and suppliers in order to promote quality awareness and to conform to customer requirements.
Identify areas for improvement and lead improvement initiatives.
Provide continued support for CER operations.
Investigate, troubleshoot and report on system failures and product defects.
Champion a structured approach to problem solving within process improvement teams.
Investigate product returned from customers or product under non-conformance.
Complete investigation reports.
Maintain control of documentation relating to the Site Production Department.
Conduct Incoming Inspections as and when required on specific materials.
Skills and QualificationsAssociate's Degree in a technical field or previous applicable work experience in a similar positionExperience in medical device is essential, two (2) to five (5) yearsGood interpersonal skills and have the ability to multi-taskMust be motivated and demonstrate the ability to be a self-starter.
Excellent communication skills with ability to interface at all levels.
Should have strong analytical, organisational and influencing skills.
Excellent computer skills.
Ability to read engineering drawingsBasic understanding of various balloon, catheter and braiding manufacturing methodsBasic knowledge of Lean Manufacturing environmentKnowledge of basic problem solving skills, such as DMAIC and PDCAOther skills that may be required or learned on the job:
MS Office suiteMinitabWorking knowledge associated with:Knowledge of ISO13485 requirementsGMP & FDA 21
CFR:
820 requirementsControlled environment per ISO 14644-XISO 14971FMEA construction and revisionsMetrology & ISO 17025 RequirementsQMS AuditorBenefitsWe offer a flexible work schedule, a comprehensive benefits package, and opportunities for growth and development
Our benefits do further include:
flexible 4 days working week; Healthcare cover; Pension contribution; Bike to work policy; Employee Assistance Program; Education Assistance policy; Engagement Company daysInterested?If you are interested in being a part of a team that is dedicated to improving the lives of patients through innovative medical technology and creating an inclusive and diverse workplace, please apply online with your CV.
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