Manufacturing Documentation Support

• Ensure that all documents are up to date, accurate, and in compliance with relevant regulatory standards.

• Assist in the creation of documents for product specifications, protocols, and 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 regulations.

• Associate's degree or higher in a relevant field (e.g., Manufacturing, Engineering, Sciences, Business Administration, etc.).

• 2-4 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, written and spoken)

• Monitor and manage the production line to ensure efficient operation and adherence to safety protocols.
• Conduct regular inspections of equipment and processes to identify areas for improvement.
• Collaborate with team members to troubleshoot issues and implement solutions effectively.
• Maintain accurate records of production metrics, including output, quality control, and downtime.
• Assist in training new employees on manufacturing processes and safety procedures.
• Participate in continuous improvement initiatives aimed at enhancing productivity and reducing waste.
• Ensure compliance with industry regulations and company policies at all times.

• Strong understanding of manufacturing processes and equipment operation.
• Excellent problem-solving skills with the ability to think critically under pressure.
• Attention to detail and a commitment to maintaining high-quality standards.
• Effective communication skills, both verbal and written, for collaboration with team members and management.
• Ability to work independently as well as part of a team in a fast-paced environment.
• Familiarity with safety regulations in a manufacturing setting is preferred.
• Proficiency in using basic computer software for record keeping and reporting purposes is advantageous. Join us as we strive for excellence in manufacturing while fostering a positive work environment that encourages growth and development!

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