Job title: Quality Engineer - Environmental, Supplier & Sterilisation
Location: Galway city
Type: Full time, permanent
- Drive ongoing compliance to particulate, LAL, bioburden requirements with respect to product, work environment and ancillary services (RO water etc.).
- Liaise with laboratory service providers, interpret results of relevant microbiological and environmental testing, monitor and report on trends to management.
- Work with Operations, R&D and Supply Chain to ensure timely qualification and ongoing performance review with regard to direct and indirect suppliers.
- Perform routine validation and requalification of sterilisation cycles to support Companys growing product portfolio (EO, radiation and other sterilisation technologies as applicable).
- Drive the execution of routine sterilisation load release in line with planned timelines.
- Resolve Quality issues in a timely manner in conjunction with all relevant stakeholders.
- Lead and contribute to continuous improvement activities as well as resolving relevant non-conformance and CAPA issues in conjunction with the wider QA, Operations, Supply Chain and R&D teams as appropriate.
Main requirements / Qualification/Experiences:
- Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher); Post graduate diploma/Masters in Quality Management desirable.
- Knowledge and experience of regulatory compliance (FDA, ISO13485, CMDR, JPAL/JGMP) and relevant industry practices.
- Experience of applying Lean Six Sigma techniques to improve business processes & performance desirable.
- Two (2)+ years experience in a highly regulated environment.
Other requirements / Abilities/skills/qualities:
- Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media. Tactful, confident, at all levels, internal and external.
- Experience as a participant in internal, supplier and 3rd party audits.
- Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to write clear and informative technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively.
- Possesses strong analytical skills and solution-driven thinking; collects and researches data. Makes good decisions based upon a mixture of analysis, wisdom, experience and judgment.
- Identifies and resolves problems in a timely manner; develops alternative solutions; works well in group problem solving situations; includes appropriate people in decision-making process.
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
- Demonstrates organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.
To apply for this position, please submit your CV (in Word format) through this website now in the strictest of confidence. Your CV will be reviewed internally in our agency and if you possess relevant experience and skills you will be contacted. Your CV will not be sent to this client or any other companies without your consent.