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 the appropriate and acceptable formats Assign document numbers; update and maintain document database. Audit official copy books and ensure corrective actions are performed when necessary. Organize, implement and maintain the 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 into the appropriate and acceptable formats. (Information should be presented in a uniform and consistent format throughout the company). Coordinate and assure that documentation is written, edited, reviewed and approved in a timely manner to meet established deadlines. Assign document numbers; update and maintain document database. Audit official copy books and ensure corrective actions are performed when necessary. Ensure all 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, control and maintain a master book and archiving with a high level of accuracy. Organize, implement and maintain the 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 and assist in training when necessary. Overall control of documentation process. Assure the correct documentation is distributed and trained appropriately. Continuously expand documented quality system throughout the entire organization. Identify areas of opportunity to improve our quality system. Become proficient to coordinate ISO audits and assist in internal audits. Assist in up-dating procedures and instructions. Continually upgrade education to current

ISO, FDA/GMP

standards and requirements. Maintain a safe and efficient work place. Perform other duties as required.

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. Detail oriented. Good organizational skills and ability to work with limited supervision. High School Diploma. What SMC has to offer? Clean, Climate-Controlled Environment Stable schedule Paid holiday and PTO Health, dental, and vision insurance 401(k) retirement savings Life and disability insurance Promotional opportunities Training and career growth programs Amazing co-workers Tuition reimbursement Employee Assistance Program 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