Document Control Specialist (12-month contract)
- Tijuana, B.C.
- Permanente
- Tiempo completo
- Coordinate all activities related to document control, maintenance, and updates within the Quality System.
- Implement and maintain the Engineering Change Notice (ECN) system for process improvements, repairs, and new process development.
- Collaborate with Engineering, Manufacturing, Quality, and other areas to ensure changes are properly documented and approved.
- Review documents to ensure alignment with the Quality Management System and applicable regulatory requirements.
- Control and update standard procedures, work instructions, drawings, quality manuals, and other documentation.
- Ensure only the latest versions of documents are available at the point of use and obsolete versions are discarded appropriately.
- Support and lead investigations (NC/CAPA) related to audit findings; assist with internal and external audit readiness.
- Lead or participate in improvement projects and system updates related to document control and change management.
- Bachelor’s degree in Engineering, Business Administration or related area
- Minimum of 3 years of experience in Document Control in a medical device or aeroespacial manufacturing environment.
- Demonstrated knowledge of 21 CFR Part 820, ISO 13485, or equivalent medical device regulations.
- Proficient in Microsoft Office Suite, including Word, Excel, PowerPoint, and Power BI.
- Bilingual Spanish and English.
- Availability to work under a 12-month contract.
- Green Belt or Continuous Improvement certification.
- Experience with Quality Systems.
- Experience with OnePLM platform.