DHR Document Control Coordinator

SMC Ltd. • Somerset, WI

8d • Onsite

About The Position

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

Requirements

• 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.

Responsibilities

• 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.
• Coordinate and assure that documentation is written, edited, reviewed and approved in a timely manner to meet established deadlines.
• 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.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED