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Quality Technician
Industry specialist
Niall Finnerty
Recruitment Consultant
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Job Summary:The Quality Technician will be responsible for supporting quality assurance activities in a medical device manufacturing environment. This role includes performing inspections, maintaining compliance with regulatory standards, and assisting with quality control processes to ensure product integrity and customer satisfaction.
Key Responsibilities:
Key Responsibilities:
- Conduct in-process and final inspections of medical devices to ensure compliance with ISO 13485, FDA, and GMP regulations.
- Support non-conformance investigations and assist in implementing corrective and preventive actions (CAPA).
- Perform routine testing, documentation, and validation of quality control processes.
- Assist in internal and external audits to ensure compliance with regulatory and company quality standards.
- Maintain accurate records and documentation for quality assurance and traceability purposes.
- Collaborate with manufacturing, engineering, and regulatory teams to improve product quality and processes.
- Support calibration and maintenance of inspection equipment.
- Provide training and guidance to production staff on quality standards and best practices.
- Diploma or Bachelor's degree in Engineering, Science, or a related technical field.
- 2+ years of experience in a quality-related role within the medical device industry.
- Knowledge of ISO 13485, FDA, and GMP requirements.
- Experience with inspection techniques, measurement tools, and documentation control.
- Strong problem-solving and analytical skills.
- Excellent attention to detail and ability to follow strict quality procedures.
- Effective communication and teamwork skills.
- Experience with CAPA, NCRs, and validation processes.
- Knowledge of statistical process control (SPC) and root cause analysis methodologies.
- Familiarity with ERP/MES systems for quality data management.
- Manufacturing floor and laboratory-based work.
- Requires attention to detail and adherence to cleanroom protocols.