Description
Our client, a leading medical device company based in Athlone, have an immediate opening for a Quality Engineer with a leading medical device company based in Athlone on a 18 month contract. This is a fantastic opportunity to join an excellent company on an initial contract basis.Key Responsibilities:
1. Key member in the design, analysis and approval of IQ, OQ & PQ protocols and reports;
2. Plan and execute validation activities within project scope and / or areas assigned to FDA requirements;
3. Establish and develop strong and effective working relationships at all levels to ensure maximum effectiveness;
4. Co-ordinate project activities associated with new process automation to ensure all aspects of the validation are being covered;
5. Work with project teams to create project schedules / timelines;
6. Risk Management - As part of a team, to co-ordinate the completion of Risk Management to include use of tools such as Failure Modes and Affect Analysis (FMEA), Control Plans, Fault Tree Analysis, etc.;
7. Provide technical back-up as required to resolve process problems;
8. Review and update of Standard Operating Procedures;
9. Completion of Validation Reports summarizing execution to a GDP standard;
10. Project manage all activities in a responsible, professional and proactive manner;
11. Execute other duties as assigned by plant management;
12. Proactively drive process improvements to reduce internal quality defects from inputs such as DMR (Defective Material Report) and rework and scrap levels. Work with manufacturing /engineering team to identify, document, investigate and remedy the cause of product non-conformance;
13. Lead deployment of root cause analysis tools and approaches through the organization with a specific focus on customer complaint reductions;
14. As part of process improvement projects, prepare process validation protocols and work with the relevant Process/Project Engineers in the execution of validations and documentation of resulting test reports;
15. Liaise with Process/Project Engineers and other departments as relevant on the revalidation/introduction of new automation/tooling /processes/software/utilities /products to ensure that all aspects of validation are being covered;
16. Suggest relevant changes to procedures and update to standard operating procedures as necessary;
17. Work with the relevant Process Engineers in defining root causes on CAPAs and determining effective corrective actions;
18. Work with supervisor in terms of establishing gaps in the plant Master Validation Plan, creating schedules/timelines to address same and regularly reviewing the Master Validation Plan for adequacy;
19. Perform process capability studies/statistical studies where required
20. Complete project work as required by Supervisor or other management personnel
SKILLS, QUALIFICATIONS and REQUIREMENTS
Minimum Requirements
* Degree in a relevant Quality /Engineering / Technology / Science discipline.
* Minimum of 4 years of professional and relevant experience in successfully executing projects from a quality engineering and validation perspective in a highly regulated / medical device environment.
General Requirements
* Team and results orientated - possess a committed and energetic approach to work with 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;
* Excellent organizational skills with ability to prioritize and work effectively on multiple tasks;
* Ability to prioritise and execute tasks in a high-pressure environment;
* Excellent written, documentation, and oral communication skills;
* Proven analytical and problem solving skills;
* Exceptional customer service orientation;
If you are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.