Quality Document Specialist

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The QA Document Specialist will be responsible for maintaining proper documentation practices to ensure compliance to FDA, ISO, and other regulatory requirements as applicable, including drafting new documents and review of records.

Duties and responsibilities

• Work with a cross-functional team to ensure all documents are properly stored and archived
• Facilitate the periodic review of documents to comply with internal QMS requirements
• Ensure completed documentation meets internal quality standards
• Draft documentation for batch records and raw material specifications
• Draft procedures for technical processes
• Data entry and basic statistical analysis
• Support the Internal Quality Audit program
• Inspection of raw material and in-process and finished products
• Assist manufacturing with batch release and other relevant documentation
• Assist with post-market monitoring of the company's products
• Assist with training and provide technical expertise as required
• Assist with supplier quality checks
• Assist with maintaining proper documentation of incoming and outgoing product
• Assist in other duties as assigned by the QA Manager

• Qualifications

• Have at least 2 years of relevant experience and a relevant bachelor's degree OR at least 5 years of relevant experience without a degree, preferably in the Medical Device industry
• Be able to work with a cross-functional team on an international stage
• Be able to communicate effectively in written and spoken English
• Be able to troubleshoot as necessary
• Be able to prioritize tasks effectively
• Show initiative and be proactive in their day-to-day tasks
• Preference for bilingual individuals that can speak and write Chinese, Spanish, French or German.

Please note that this position is 100% in the office.