Quality Systems Specialist
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We are seeking a Quality Systems Specialist will collaborate with cross-functional teams to support documentation accuracy, regulatory compliance, and the implementation and maintenance of quality system requirements. Responsibilities Support the execution of QMS activities and corrective action plans. Assist in ensuring Quality System processes comply with applicable regulatory requirements, company policies, and industry standards. Draft, review, revise, and maintain controlled quality documentation, including SOPs, Work Instructions, Forms, and Templates. Support track remediation activities and provide status updates to Quality Management. Participate in continuous improvement initiatives by identifying opportunities to enhance processes and maintain compliance.
Requisitos:
Bachelor's degree in Science, Engineering, or a related technical discipline. 2-3 years of experience in a regulated medical device, pharmaceutical, biotechnology, or life sciences environment. Experience writing, revising, and maintaining controlled procedures and quality system documentation. Experience supporting Quality Management Systems (QMS). Familiarity with Change Control and Deviation Management processes. Strong organizational skills and attention to detail. Effective written and verbal communication skills.
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