Quality Engineer
Cork - Mitchelstown
Job Spec, Quality Engineer
Key Responsibilities
Documentation: Preparing and maintaining documentation to meet regulatory, perform and review process and equipment validations, IQ, PQ and OQ
Support ISO9000/ISO13485 Quality Systems: Ensuring the company’s quality management system aligns with these international standards, which are crucial in the medical devices industry.
Regulatory Compliance: Ensuring that all activities meet external regulatory requirements.
Leadership Role: Being a key member of the Engineering Team, leading the Quality Team through daily management, performance reviews and customer audits
Continuous Improvement: Supporting programs like Six Sigma to enhance processes and product quality.
Quality System Management: Overseeing systems related to production support, such as non-conformance, incident reporting, and customer complaint analysis.
Customer Interaction: Liaising with key external customers, to ensure that quality standards meet customer expectations.
CAPA Management: Ensuring Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards.
GMP Oversight: Ensuring Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities.
Education & Experience Requirements
Industry Experience: At least 2+ years in an ISO environment, preferably in the medical devices or pharmaceutical industry.
Technical Knowledge: Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous. Advanced Technical writing skills are required.
Process Expertise: Experience in process validation.
Degree level 8 or level 8 with experience
Job Type: Part-time
Pay: €40,000.00 per year
Work Location: In person
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