Manufacturing Project Engineer (12-Month Contract)
Location: County Cork, Ireland
Company Overview: A leading global medical device company based in County Cork is seeking a Manufacturing Project Engineer on a 12-month contract. The role will focus on supporting regulatory compliance, validation, change control, and project execution in a fast-paced manufacturing environment.
Key Responsibilities:
* Regulatory Compliance: Ensure adherence to medical device regulations (ISO 13485, FDA, MDR) in manufacturing processes.
* Validation: Lead and execute validation activities (IQ/OQ/PQ) for equipment, processes, and systems.
* Change Control: Oversee and support change control processes, ensuring proper documentation and approval.
* Project Execution: Assist in managing project tasks, timelines, and deliverables, working with cross-functional teams.
* Documentation: Maintain clear documentation for validation, change control, and project progress.
Required Skills and Experience:
* 3+ years of experience in medical device manufacturing, including regulatory compliance and validation.
* Strong knowledge of FDA, ISO 13485, and EU MDR regulations.
* Experience in change control processes and project task execution.
* Excellent attention to detail, communication, and problem-solving skills.
* Ability to work in a cross-functional team and manage multiple priorities.
Contract Duration: 12 months, with potential for extension.
Application Process: Please submit your CV and cover letter outlining relevant experience.
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