Manufacturing Documentation Support role plays a key part in ensuring that all manufacturing documentation for medical devices is properly created maintained and compliant with regulatory standards. Expertise in reviewing validation data on manufacturing equipment specifically in CSV.
Responsibilities:
- Develop review and maintain manufacturing documentation including Standard Operating Procedures (SOPs) Work Instructions Batch Records and Equipment Maintenance Logs.
- Ensure that all documents are up to date accurate and in compliance with relevant regulatory standards.
- Assist in the creation of controlled documents for product specifications testing protocols and design history files.
- Support the compliance of manufacturing documentation with regulatory requirements and internal quality standards.
- Coordinate with the Quality Assurance (QA) team to ensure the manufacturing processes and documentation adhere to industry regulations and company policies.
- Assist in internal audits and document reviews to ensure compliance with regulatory and ISO standards.
Requirements
- Associates degree or higher in a relevant field (e.g. Manufacturing Engineering Sciences Business Administration etc..
- 24 years of experience in a manufacturing or quality assurance role in the medical device industry with a focus on documentation or regulatory compliance.
- Bilingual (English & Spanish)