Our client, a medical device company in Galway are currently looking to recruit a Quality Engineer III for their site.
The ideal candidate will:
- 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 the company?s 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.
- 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.
- Minimum of 2 years? experience in a highly regulated environment.
Candidate should also have the following 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.