Job Description
DEPARTMENT: Quality Department
REPORTING TO: Lead Quality Engineer – Validation / NPI
DIRECT REPORTS: N/A
OBJECTIVES OF POSITION:
1. To formulate and execute validation plans for medical devices.
RESPONSIBILITIES:
2. Support validation activities in a Medical Device regulated environment.
3. Support Process Validation Execution in Fermoy.
4. Support Software Validation Execution in Fermoy.
5. Assist with resolution of Problems encountered during validation.
6. Become fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
7. Participate in change control processes for manufacturing process and facility modifications.
Quality:
8. Assure ongoing compliance with quality and industry regulatory requirements
Health & Safety:
9. Ensure compliance with Health & Safety Legislation and Regulations.
10. Please send all applications with a copy of your CV to by 19 Jul 2024
MEASUREMENTS:
11. Timely and accurate completion of Validations.
12. Compliance with regulatory Standards and requirements.
PERSONNEL SPECIFICATIONS
ESSENTIAL:
13. Minimum Level 7 Degree/ Diploma (Preferably in a Science, Electronics, Mechanical or Industrial Engineering)
14. Sound understanding and utilization of Problem Solving Techniques
15. Proficient in the use of MS Word, Power-point and Excel.
16. Ability to write standard operating procedures, training documents, and regulatory responses.