• Maintain document change control process via engineering change control system (log, track and process DCOs, maintain material and BOM data)
• Review revised documents and completed change orders to assure the highest level of accuracy, completeness and conformance with the approved format and standards
• Review, process, and release documents using variety of software packages.
• Ensure documents and records are retained per company procedures and regulatory requirements.
• Maintain electronic files of master active or archived documents (native source application files as well as the .pdf viewable files)
• Review Quality Records for adherence to Good Documentation Practices (GDPs) and compliance to governing procedures.
• Assist in the data entry setup of training sets for new hires that may include technical and Quality Management System procedures when needed.
• Assist in the data entry of employee training records when needed

Requirements

• Experience in technical documentation and the change control process using an engineering change control system in the medical device industry is required.
• At least 1 year of relevant experience working in the medical device industry is required.
• Bachelor’s Degree or advance studies on Engineering or related field, Translation, English or Linguistics.
• Proficiency with MS word, excel and other database systems.
• Strong organizational skills with the ability to work in a fast-paced environment while managing multiple priorities
• Must have strong written and verbal skills, and be able to effectively communicate with all levels of the organization
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• High attention to detail with ability to self-audit work and ensure compliance with documentation and quality requirements.

No sponsorship available. Must be legally eligible to work in the US. Please submit resumes via Linkedin (vs messaging).