DHR Document Control Coordinator

About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

POSITION SCOPE AND PURPOSE: Responsible for the preparation and control of documentation according to ISO 9001, ISO 13485, and SMC’s Quality Systems requirements.

KEY ACCOUNTABILITIES/ESSENTIAL FUNCTIONS:

• Work with all departments to translate their documentation into theappropriateand acceptable formats
• Assign document numbers; update andmaintaindocument database. Audit official copy books and ensure corrective actions are performed when necessary.
• Organize,implementandmaintainthe system for controlling the generation and revision of all documents. Coordinate the review and revision of procedures, specifications, forms, etc.
• Regular attendance.

LIST OF POSITION DUTIES:

• Work with all departments to translate their documentation intothe appropriateand acceptable formats. (Information should be presented in a uniform and consistent formatthroughout thecompany).
• Coordinate andassurethat documentation is written, edited,reviewedand approvedin a timely mannerto meet established deadlines.
• Assign document numbers; update andmaintaindocument database. Audit official copy books and ensure corrective actions are performed when necessary.
• Ensureall ISO documentation is current to the company’s procedures and activities.
• Develop manufacturing processes and improve existing processes with updates. Work with production and shifts to communicate changes and updates.
• Prepare,controlandmaintaina master book andarchiving witha high levelof accuracy.
• Organize,implementandmaintainthe system for controlling the generation and revision of all documents. Coordinate the review and revision of procedures, specifications, forms, etc.
• Revise ISO Quality System procedures andassistin training when necessary.
• Overall control of documentation process. Assure the correct documentation is distributed and trained appropriately.
• Continuously expand documented qualitysystemthroughout the entire organization.
• Identifyareas of opportunity to improve our quality system.
• Become proficientto coordinateISO audits andassistin internal audits.
• Assistinup-datingprocedures and instructions.
• Continually upgrade education to current ISO, FDA/GMP standards and requirements.
• Maintain a safe and efficientwork place.
• Perform other duties asrequired.

QUALIFICATIONS:

• Knowledge of quality systems such as ISO and FDA/GMP regulatory requirements.
• Three years’ experience working in documentation control.
• Proficient with Excel and Word.
• Excellent communication skills, strong presentation, interpersonal, and planning skills.
• Ability to multi-task and prioritize work. Detailoriented.
• Good organizational skills and ability to work with limited supervision.
• High School Diploma. 

What SMC has to offer?

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. 

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

#IND

#LI-HN1