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 role
As 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 Responsibilities
General Duties
Provides 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 audits
Supports maintenance of Quality System implementation.
Specific Duties and Responsibilities
Review 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 Qualifications
Associate's Degree in a technical field or previous applicable work experience in a similar position
Experience in medical device is essential, two (2) to five (5) years
Good interpersonal skills and have the ability to multi-task
Must 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 drawings
Basic understanding of various balloon, catheter and braiding manufacturing methods
Basic knowledge of Lean Manufacturing environment
Knowledge of basic problem solving skills, such as DMAIC and PDCA
Other skills that may be required or learned on the job:
MS Office suite
Minitab
Working knowledge associated with:
Knowledge of ISO13485 requirements
GMP & FDA 21CFR:820 requirements
Controlled environment per ISO 14644-X
ISO 14971
FMEA construction and revisions
Metrology & ISO 17025 Requirements
QMS Auditor
Benefits
We 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 days
Interested?
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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