||Offaly, Westmeath, Longford
||Third Level Degree
Quality Assurance Engineer
My client a leading Medical Device company based in Westmeath, in conjunction with the CPL Group, is looking to recruit for a Quality Assurance Engineer.
- The candidate will be a key member in the design, analysis and approval of IQ, QQ & PQ protocols and reports.
- Ensure the execution of validation activities is within project scope and / or areas assigned to the FDA requirements.
- Ensure all aspects of the validation are being covered by co-ordinating project activities with new process automation.
- Project manage all activities in a responsible, professional and proactive manner.
- Proactively drive process improvements to reduce internal quality defects from inputs such as DMR (Defective Material Report) and rework and scrap levels.
- Lead deployment of root cause analysis tools and approaches through the organization with a specific focus on customer complaint reductions.
- Liaise with Process/Project Engineers and other departments as relevant on the revalidation & introduction of new automation products to ensure that all aspects of validation are being covered.
- Work with the relevant Process Engineers in defining root causes on CAPAs and determining effective corrective actions.
- Planning and execution of Protocols, Validations and CAPA activities.
- Ensure the full understanding of and implementation of the company’s GMP Policy.
- Minimum of 4 years of experience in successfully executing projects from a quality engineering and validation perspective in a highly regulated & medical device environment.
- Degree in a relevant Quality Engineering Science discipline.
- Team and results orientated – possess a committed and energetic approach to work with a positive attitude.
- Knowledgeable in Quality Systems and Validation standards, policies, procedures and methodologies.
- Knowledgeable in the understanding and execution of GAMP5.
- Strong problem-solving and critical thinking skills.
To apply or to discuss this position further, send your CV to email@example.com or call me on 01-6146007 for a confidential conversation.