Job Description

The Quality Engineer is more visible to shop floor, will support Quality at Source (QaS) initiatives & other Quality and process improvements through the use of chemistry or chemical engineering knowledge, SPC, Process Capability, and Quality tools. Provides leadership for handling of nonconformance/CAPA’s/Complaints, etc. The role drives and supports key quality system activities such as internal audits, process and product audits, documentation review and the enforcement of Good Manufacturing Practice (GMP) standards. Provides key supports to validation activities, generation and review of process risk assessment (e.g. pFMEA), and development or implementation of in-process controls, tests, checks, and inspection to support process and continuous improvement initiatives.

• Provides key support for or lead the implementation of Quality at Source (QaS) and all quality & CI related projects for process improvement, cost savings, etc.
• Utilize Quality Engineering tools and techniques to perform and document root because analysis investigations, evaluate and resolve quality issues, and to enhance continuous improvement.
• Develop and implement in-process testing/controls to support continuous improvement initiatives, process improvements to address operational issues e.g. via NC, CAPA, New Product Introduction.
• Leads/Participate/supports continuous improvement initiatives, process improvements to address operational issues using statistical process control (SPC) and Quality tools e.g. pareto, process capability, correlation analysis, etc.
• Leads/Participate/supports generation of new and review of current process risk assessment e.g. pFMEA.
• Leads/Supports and process NC and/or Corrective and Preventive Action (CAPA) programme for the Rhymney site as required to address operational issues including complaints and continuous improvement initiatives.
• Supports validation activities e.g. execution and review of IQ, PQ, NSPR, Engineering Studies
• Supports the Internal Audit programme at the Rhymney site to assure compliance to Quality Systems standards such as ISO, QSR, and the Quality Management System. Performs internal audits as per the audit schedule.
• Supports and / or provides SME input for external audits.
• Supports quality department projects to ensure the highest standards of compliance and on time delivery. Represent QA on site wide project teams.
• Develops and reports quality assurance KPI’s as required. Collates quality data and presents for management review.
• Updates documentation within the quality management system in compliance with D2 and the company change control programme.
• Supports compliance with and maintenance of quality system documentation in line with regulatory standards including ISO 13485, 21 CFR Part 820. Improve and drive performance of quality system processes in order to meet quality and site KPI’s.
• Support the general activities within the Quality Department.
• Deputizes for Quality System Engineer or QA Lead or Associate Quality Manager as required.

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.

Required Knowledge, Skills, and Abilities

Chartered Quality qualification. Degree level education and / or equivalent experience in a scientific discipline. Chemisty or Chemical Engineering or related degree. Six Sigma green belt qualified and / or demonstrated ability in the use of quality engineering tools and techniques and data interpretation. Experience in quality management and the application of ISO 13485 and 21 CFR: Part 820, in the medical device industry. Experience in implementation, management and improvement of Quality System processes (e.g. Calibration / Audit / NC / CAPA / Change Control / Validation) gained in a quality assurance function within the medical device industry. Sufficient experience gained in a quality engineering environment to demonstrate a thorough understanding of a risk-based quality approach, and material disposition. A practical working knowledge of implementation of change control, and of all aspects of the process and computer systems validation lifecycle. Demonstrated ability to lead multiple projects and motivate cross functional teams whilst ensuring that deadlines are met. Competent auditor. Experience in hosting or acting as SME during external regulatory audits. Analytical testing background and test method validation experience. Experience in implementing/review of pFMEA. Experience in Validation execution e.g. IQ, OQ, PQ, DoE. Experience in implementing (use of) SPC, process capability, and Quality tools.