The Quality Technician will provide Quality support of any area assigned and is responsible for adhering to current revision of ISO 13485 Standard, FDA QMSR and internal QMS procedures and practices.
The Quality Technician position provides Quality support associated with material/product inspections, work order (batch record) review/approval, final product release and associated documentation creation and revision.
The Quality Technician position is involved in the following QMS processes at a minimum: Incoming inspection, In-process inspection, Final Inspection/Release, Non-Conformance, Customer Complaint, Quality Auditing, CAPA process, Engineering Change Order process, Documentation control, Environmental monitoring process, Key Performance Indicator Process, Stock Checks, and Documentation Control.
The associate in this role has the authority and responsibility to:
- Ensure compliance with relevant standards/regulations, as well as company standards and specifications
- Ensure QC equipment calibration is maintained
- Perform inspections across all stages of Production and Quality Control
- Prepare and maintain test data for review
- Evaluate data and draft reports, noting any relevant deviations/non-conformances from existing standards
- Identify areas for improvement and implement new methods accordingly
- Communicating quality or compliance concerns to the Management Team
- Actively participate in new product introductions as a quality representative
- Actively participate in new process introductions (e.g. ERP system introduction, Training system introduction, e-Documentation system introduction)
- Support Documentation Control activities
- Support Environmental Monitoring program
- Support the Auditing program.
Qualifications
· Quality Certificate/Diploma/Degree in a relevant field (e.g. Quality, Science/Engineering)
· Experience with inspection and testing techniques.
· Strong attention to detail and accuracy.
· Proficiency in using measurement tools and equipment.
Skills
· Excellent problem-solving and analytical skills.
· Strong communication and interpersonal skills.
· Ability to work independently and as part of a team.
· Proficiency in using Quality Management tools and software.
· Strong Organizational and time management skills.
· Ability to train other members of Quality department on internal processes.
· Ability to use ERP Systems e.g. Oracle, Syspro, SAP.
· Responds positively to changes in procedures, regulations and technologies.
· Demonstrates willingness to learn new quality tools, systems and standards.
Experience
· Minimum 2-3 years of experience in a Quality Control and/or Quality Assurance role.
· Experience in a manufacturing or production environment.
· Familiar with ISO standards and regulatory requirements (e.g. FDA QMSR)
· Experience with ISO13485 and regulatory audits.
· Experience with new product introductions beneficial.
· Experience of new process introductions and associated validations e.g. ERP systems, beneficial.
Pay: €40,000.00-€45,000.00 per year
Benefits:
- Bike to work scheme
- Company pension
- Employee assistance program
- On-site parking
- Private medical insurance
Work Location: In person
