Document Control Specialist (12-month contract)
Document Control Specialist (12-month contract)
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Job Description
What you will do
Responsible for coordinating and maintaining the documentation processes related to internal and external procedures policies and quality standards. You will support the implementation and maintenance of the Engineering Change Notice (ECN) system and ensure alignment across cross-functional teams. This role is key in driving compliance supporting audits and ensuring document integrity within the organization.
Responsibilities and Functions
- 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.
What you need
Required:
- Bachelors 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.
Preferred:
- Green Belt or Continuous Improvement certification.
- Experience with Quality Systems.
- Experience with OnePLM platform.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
