Job Description

My client is a market leading innovation company who are looking for an Quality Engineer to cresponsible for ensuring that product and business system processes meet regulatory and customer quality standards. Responsible for identifying and raising quality issues and working to resolve them, including working directly with customers. Work in a team environment to develop and implement quality best practices and support continuous improvement as part of the Quality Team.

Your responsibilities:

Business System Development

• Lead and support development and maintenance of business systems, procedures and documentation
• Lead and support certification to new or existing Regulatory Standards (e.g. ISO9001:2015)
• Conduct internal audits throughout the audit cycle and drive associated improvement activities
• Conduct system administration and work to streamline quality and business processes

Production Quality Engineering Support

• Provide Quality Engineering support to manufacturing to maintain OTD and Quality requirements
• Review product concession and deviation notices for suitability prior to approval
• Manage and drive all Material Review Board (MRB) life cycle processes including investigation and disposition
• Manage reporting of all Customer Returns (RMAs) and ensure they are processed as required
• Ensure all manufacturing change and NPI embeds Quality methodologies (Human Factors, Poka-Yoke, MSA etc)
• Lead Root Cause Analysis and Corrective Action (RCCA / CAPA) methodologies such as DMAIC, 8D, 5W & 6M etc
• Support design & development activities - assist Engineering teams to ensure that designs are appropriately reviewed, verified and validated throughout the development process
• Participate in the development and refinement of Design and Process FMEA's (Failure Mode and Effects Analysis)
• Generate and maintain documentation such as SOP's, calibration, test procedures and Inspection and Control Plans
• Conduct statistical analysis including Statistical Process Control (SPC) or Measurement Systems Analysis (MSA)

Quality Assurance & Auditing

• Work with internal and external stakeholders to resolve quality issues that arise to prevent compromising standards
• Support Supply Chain Quality non-conformance and development activities - reject management, inspection etc.
• Carry out internal and supplier product & process audits in line with ISO 9001:2015 requirements
• Investigate customer complaints, report findings and non-compliances and implement corrective actions
• Carry out data analysis and report on trends on Key Performance Indicators (KPIs) (e.g. Scrap, Warranty etc.)
• Preparation of internal and external Quality Reports and presentations as required

General:

• Act as back-up support for Quality Manager if required
• Train both team and broader organisation members
• Lead and / or support groups of technicians or engineers in quality activities
• Perform ad hoc tasks as required
• Keep up to date with developments and trends in Quality Best Practices and Regulatory Standards

Who are you:

• Experience in a Quality Engineering / Assurance role in a relevant manufacturing industry.
• HND / BTEC / NVQ Level 4 in Engineering or Quality
• ISO 9001:2015 Internal Auditing qualification and internal auditing experience
• Good working knowledge of ISO9001:2015
• Experience of CI Methodologies (5S, LSS etc)
• Experience of working with customers and suppliers
• Knowledge of 8D problem solving, RCCA tools as well as APQP,PPAP and FMEAs
• Ability to write and submit Quality reports and familiar in Material Review Board (MRB) processes
• Experience of working with ERP systems
• Good working knowledge of Microsoft Office Tools
• Able to interpret manufacturing documentation
• Experience in Optical / Mechanical / Electronic / Hi-tech manufacturing / process engineering
• Experience in ISO cleanroom or similar GMP environments
• Educated to degree level (or equivalent) in Engineering or Quality discipline
• Lean Six Sigma Green or Black Belt Certified
• Experience using SAP
• Membership of an industry related Professional Body would be advantageous
• Non-Smoker/Vaper

Start Date ASAP, working hours will be 37.5 hours per week
Due to the site rules the successful candidate must be a non-smoker/Vaper

If you are interested in this role, please contact Vanessa at 02380 683 444 or apply now