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Document Control Coordinator
hace 3 meses
Vacancy Name
- Document Control Coordinator
Location of Work
- Tijuana, Mexico
Employment Type
- Full Time Employee
Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
-Remarkable service
A seamless, personal process designed around you and your needs.
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Trusted performance
Our product family is the result of years of experience championing surgeons and listening to their expertise.
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Outstanding value
No matter the surgical specialty, we deliver quality products for all markets.
Our people promise
Excellence is our Specialty and what makes us successful is our people.
We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas.
That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
-Job Purpose Summary
The role of Document Control Coordinator is to ensure that document control process is being done according to procedure, regulations and timeline and to facilitate change control activities from any requiring department to the Document Control team.
This role assists in internal & external audits, review and provide guidance to engineers in generating change requests (CR) & for all documents to comply with Document Control procedures, applicable standards and regulations.
The role also provides support to Customer Service, Marketing, Regulatory Affairs & Distribution Center on system issues and maintenance. Back-up for Veeva Configuration Specialist.Job functions include, but are not limited to the following:
- Supervision/Coordination of activities within the Document Control area (personnel).
- Process product changes and new product introduction in Veeva & D365 systems based on approved Change Requests.
- Process documents and product specifications in Veeva.
- Scan and control files of product specifications and documents.
- Ensures that Document Control, Change Request and DHR Control processes are properly followed.
- Ensures that documentation is issued and reviewed in accordance with good manufacturing practices, ISO 13485, CFR 21 Part 820 requirements and other applicable standards and regulations.
- Maintains the revision of documents and ensures all procedures are updated as needed within the Quality Management System.
- Support to internal & external audits.
- Provide assistance to users in Veeva & D36
- Assists on the development of procedures, processes and change requirements for applicable areas in Document Control.
- Assign and control temporary deviations.
- Periodic QMS documentation review External Document and Standards control and management.
What you will need
Establish direction, plan, and organize workloads by estimating, scheduling, distributing, and controlling work assignments to provide for a smooth flow of both priority and routine tasks to achieve economical and efficient utilization of personnel and facilities.
Ensure key business metrics are achieved within the area and drive corrective action of related non-conformances. Identify and resolve performance problems within the document control process. Promote a strong sense of teamwork among personnel throughout and across the area. Provides leadership consistent with the Mission and Guiding Principles. Serve as the focal point to communicate and resolve issues within their area and other internal customers. Coordinate with internal customers as necessary to ensure commitments are achieved. Facilitate problem solving and collaboration. Identify errors and initiate corrective action while monitoring the quality date to ensure the effectiveness of the corrective action. Support corrective action reviews and participate in identifying root causes and corrective actions within the processes of the area. Performs other related duties as required. Professional career. 2 to 5 years of experience. Advanced English preferred.-
What we value
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Customer First
- We deliver extraordinary experiences.
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Accountability
- We do what we say.
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Integrity
- We do what is right.
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Inspired
- We love what we do.
One Global Team
- We before me, always.
- **_Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics._
