REPORTING TO: Lead Quality Engineer – Validation / NPI
DIRECT REPORTS: N/A
OBJECTIVES OF POSITION:
* To formulate and execute validation plans for medical devices.
RESPONSIBILITIES:
* Support validation activities in a Medical Device regulated environment.
* Support Process Validation Execution in Fermoy.
* Support Software Validation Execution in Fermoy.
* Assist with resolution of Problems encountered during validation.
* Become fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
* Participate in change control processes for manufacturing process and facility modifications.
Quality:
* Assure ongoing compliance with quality and industry regulatory requirements.
Health & Safety:
* Ensure compliance with Health & Safety Legislation and Regulations.
MEASUREMENTS:
* Timely and accurate completion of Validations.
* Compliance with regulatory Standards and requirements.
PERSONNEL SPECIFICATIONS
ESSENTIAL:
* Minimum Level 7 Degree/ Diploma (Preferably in a Science, Electronics, Mechanical or Industrial Engineering).
* Sound understanding and utilization of Problem Solving Techniques.
* Proficient in the use of MS Word, Power-point and Excel.
* Ability to write standard operating procedures, training documents, and regulatory responses.
#J-18808-Ljbffr