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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, PowerPoint, and Excel.
* Ability to write standard operating procedures, training documents, and regulatory responses.
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