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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. xcfaprz
Application Process: Please submit your CV and cover letter outlining relevant experience.
Sprachkenntnisse
- English
Hinweis für Nutzer
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