Quality Engineer

Job Summary: 

Plans and conducts activities concerned with the quality control and quality assurance of products manufactured in cleanrooms under ISO 9001:2015

*Essential Job Duties:

• Work as part of a value stream to ensure appropriate quality oversight and support to operations
• Drive continuous improvement and embed a culture of quality to ensure ongoing compliance with ISO9001:2015 standards
• Troubleshoot complex problems as part of a cross functional value stream
• Ensure the QMS is in place, in use and aligned to current regulatory expectations
• Design and implement test plans and audits for products to ensure product quality targets are met
• Establish, define, implement, maintain, and report on quality assurance key performance measures and standards
• Investigate non-conformances and consumer complaints, perform root cause analysis, implement corrective actions, and monitor progress and improvements
• Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions
• Perform quality assurance and qualification audits on vendors/suppliers
• Participate in and host customer audits of the facility
• Devises sampling procedures, design and develop forms and instructions for recording, evaluating, and reporting quality data
• Write technical reports
• Coach and support others in relation to quality best practices as required

Qualifications:

• Bachelor of degree in Engineering, Science or equivalent
• 4+ years of experience working in a regulated environment (ISO accredited, Pharmaceutical, medical devices etc.)
• Familiarity with cleanroom manufacturing
• Working knowledge of Microsoft Office applications
• Experience in general quality systems (internal and external audits, CAPA management, customer complaints handling, non-conformance management etc.)
• Ability to articulate complex problems in a clear concise manner through effective communications and technical report writing skills
• Strong analytical problem solving skills
• Demonstrated ability to work collaboratively as part of a cross functional team

Interested candidate shsould submit an up to date CV to be considered for the role or contact Sean on 0214297900 or Sean.Barron@peglobal.net