October 8, 2024

Cirtec Medical Corporation

Alajuela

OTHER

Document Control Specialist II

About us:
For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenge, you may be a perfect fit for our team!
Position Summary:
The Document Control Specialist processes Engineering Change Orders and coordinates employee training configurations in the Employee Training System. Engineering Change Order processing includes coordinating interactions between engineering, manufacturing, operations, and customers to ensure complete and accurate process flows and results compliant with policies and procedures.
Key Responsibilities:

Processing Engineering Change Orders in the Electronic Data Management Systems.
Entering or verifying data in ERP systems.
Communicating with customers.
Ensuring Change Order Items, Structure, Attributes and Supporting documents are appropriately documented and correctly structured on the ECO.
Reviewing Change Order Information, assigning required approvers, verifying all documents and items meet procedure requirements.
Maintaining related Document Control files within and outside the EDMS
Verifying the post-ECO data is correct and ensuring documents are filed correctly and maintained per established procedure.
Entering employee training into the Employee Training Systems including setting up new employee accounts and training.
Create, archive, and maintain distribution of procedure hard copy controlled documents distributed to the production areas.
Understand the concept of Data Management entry into an ERP System (i.e. Building of Manufacturing, Distribution though-out the process of Development and Production.
Maintain the external standards library.
Manage offsite document storage.
Supporting and participating in audits.
Other projects as needed for compliance and continuous improvement.

This is not a remote position.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Must Have:

3-5 years of Document Control experience in the Medical Device Industry or equal required.
Prior experience with PLM software systems, such as Oracle or Master Control.
Strong knowledge in implementing, processing, and maintaining company and customer

documentation in ERP and PLM Software System.

Detail-oriented.
Flexible and motivated attitude.
Must be able to read, write and speak fluent English.
Proficient with MS Word and Excel. (Word, Excel, Visio, Power Point)
Knowledge of document control procedures with data storage, maintenance, revision, and

archival background.

Ability to travel internationally.

Good to have:

Familiarity with FDA Quality System Regulation (QSR) and ISO 13485.

Working Environment:

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Cirtec Medical Corporation considers everyone for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all its related companies fully endorse equal opportunity. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create an enjoyable work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Our benefits include training and career development, healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.