DOCUMENT CONTROL SPECIALIST
With continued business growth and expanding engineering initiatives, CS Medical has an immediate opportunity for a full-time Document Control Specialist. CS Medical is a leading manufacturer of FDA registered disinfectors used in hospitals worldwide. The company has patented devices that provide high level disinfection for ultrasound intra-cavity probes.
Our products incorporate temperature critical fluidics, microprocessor control and data transfer, interactive human interface and electromechanical design components. The company installs and services its systems throughout North America and has international distributors in countries worldwide. We operate in an ISO 13485 quality environment and are an FDA registered manufacturer.
JOB TASKS, DUTIES, AND RESPONSIBILITIES
As part of the quality team, you will be responsible for various quality system activities providing guidance on US and international quality system requirements; as well as the development and maintenance of documents to demonstrate compliance to quality system requirements.
The document control specialist position collects, maintains and distributes all documents necessary to define regulatory requirements; develops and maintains a comprehensive filing system and computer database for all documents to be retained in the document control center; manages the operation of the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner.
• Collect and maintain files of the latest revision level documentation
necessary to define regulatory requirements.
• Handle and maintain FDA/EU regulatory compliance activities related to
• Process Improvement Initiatives.
• Provide documentation to all appropriate users and ensure that
obsolete documentation is removed from distribution.
• Maintain a computer database of all filed documentation that ensures
fast retrieval of documents.
• Create and Maintain Standard Operating Procedures for manufacturing
• Demonstrated working knowledge and a history of successfully
implementing quality system elements related to medical device
manufacturing, including, but not limited to: Non-conforming material
investigations, CAPAs, and document change controls.
• Ability to exercise independent judgement within defined procedures
and practices to determine appropriate action.
• Familiarity with standard measurement equipment: micrometers,
calipers, multimeter, etc.
• Ability to use logic to solve problems.
• Ability to provide guidance and training to company peers.
• Working knowledge of FDA/EU medical device regulations, guidance
documents, and international standards (ISO 13485 and 14971).
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelors degree in science, engineering or technical field from an
accredited college or university, or equivalent work experience
• A minimum of 3-5 years’ experience working with FDA/EU regulated
medical devices (Class II minimum)
• Experience developing SOPs, work instructions, Design History Files,
Technical Files and other supporting documents to address domestic
and international regulatory requirements
• Excellent written and verbal communication skills
• Fluent in English (speaking, reading and writing)
• Excellent organizational skills
• Proficient with MS Office Suite (Word, Excel, Project, Access,
• Ability to manage multiple projects simultaneously
• Statistical software experience (MiniTab or equivalent)
• ASQ CQE or CSSBB desired
This position will be based at our Creedmoor, NC office
TERMS OF EMPLOYMENT
This is a full-time, non-exempt, hourly position.
The general hours shall be Monday – Friday, 8:00am to 5:00pm with an
hour break for lunch.
Work is regularly performed in office and warehouse environments.
The physical demands described here are representative of those that
must be met by an employee to successfully perform the essential
functions of this job. The employee is frequently required to sit. The
employee is occasionally required to stand and/or walk. The employee
must occasionally lift, carry, push or pull up to 20 pounds.
No travel required other than travel between office locations.
Compensation package includes 401K plan, Paid Time Off, and health
insurance once full-time permanent status is attained.
HOW TO APPLY
To apply for this position, please submit your resume and cover letter. CS Medical is an equal opportunity employer. CS Medical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, age, disability or genetic information. For further information about us please visit our website at www.csmedicalllc.com.