Quality Documentation Specialist
5 days ago
The Quality Documentation Specialist will maintain proper documentation practices to ensure compliance with FDA, ISO, and other regulatory requirements. This includes drafting new documents and reviewing records.
Duties and Responsibilities:- Collaborate 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.
- Evaluate completed documentation for adherence to internal quality standards.
- Draft documentation for batch records and raw material specifications.
- Create procedures for technical processes.
- Perform data entry and basic statistical analysis.
- Support the Internal Quality Audit program.
- Inspect raw materials, in-process products, and finished goods.
- Assist manufacturing with batch release and other relevant documentation.
- Aid post-market monitoring of company products.
- Provide training and technical expertise as required.
- Conduct supplier quality checks.
- Maintain accurate documentation of incoming and outgoing products.
- Perform other duties assigned by the QA Manager.
- Minimum 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.
- Ability to work with a cross-functional team on an international stage.
- Effective communication skills in written and spoken English.
- Troubleshooting and prioritization skills.
- Proactive approach to day-to-day tasks.
- Preference for bilingual individuals fluent in Chinese, Spanish, French, or German.
This is a full-time position located in the office.
Estimated Salary: $60,000 - $80,000 per year.
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