This role is responsible for ensuring product quality, regulatory compliance, and customer satisfaction within the manufacturing environment.
It acts as the main interface with customers on quality performance, managing complaints, returns, and improvement initiatives.
The position oversees quality systems and documentation (such as DMR/DHR and technical files), monitors quality metrics and process performance, and conducts data analysis to drive continuous improvement.
It also supports new product introduction (NPI) through inspections and approvals, and manages CAPA, non-conformances, and validation activities (IQ/OQ/PQ).
Additionally, the role ensures compliance with industry and regulatory standards (FDA QSR, ISO, ISO ) and conducts internal audits to maintain an effective quality management system while supporting health and safety regulations.
Required: ·Minimum NFQ Level 7 qualification in Science or Engineering, or equivalent experience in a related field.
·2–3 years of experience in Quality Assurance or Regulatory Affairs, preferably in a Quality Engineering role within the electronics manufacturing industry.
·Strong understanding and application of problem-solving methodologies.
·Proficiency in Microsoft Office applications, particularly Word, Excel, and PowerPoint.
·Excellent communication and interpersonal skills, with the ability to influence stakeholders.
·Ability to effectively respond to internal customer inquiries, complaints, and regulatory requests.
·Experience in developing standard operating procedures (SOPs), training materials, and regulatory documentation.
Desirable ·Experience working in a Medical Device Manufacturing environment or a similarly regulated industry.
·Six Sigma Green Belt or Black Belt certification.
·Experience supporting New Product Introduction (NPI) processes.