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Sterile Medical Devices Professional
3 weeks ago
We are seeking a highly skilled professional to fill the Sterile Medical Devices Professional position at Link Compliance in Malaysia.
Main ResponsibilitiesDevelop and implement strategies to enhance our quality management system in accordance with FDA regulations and standards.
Provide technical expertise in drafting, revising, and reviewing QMS-related documentation and coordinating internal and external communication.
Collaborate with stakeholders to ensure effective communication and coordination on quality management-related matters.
Conduct regular audits and assessments to identify areas for improvement and implement corrective actions.
Perform other duties as assigned by management.
A Bachelor's degree or above, with at least 4 years of experience in sterile medical consumables; experience in the endoscopy field is preferred.
In-depth knowledge of ISO 13485, GMP, MDD standards, and relevant regulatory requirements.
Certified internal auditor with proven experience independently managing at least two full product lifecycle projects from R&D to production.
Strong communication, learning, and teamwork abilities with good stress management skills.
