Documentation Control Specialist
4 days ago
At Quality Tech Services, LLC, we are seeking a highly organized and detail-oriented Documentation Specialist to join our team. As a key member of our quality team, you will be responsible for coordinating all phases of document control, verification of documentation control requirements, and maintenance of various files, records, and logs.
Key Responsibilities:
- Perform, maintain, and improve documentation control activities and procedures, document control system, and release and distribution activities.
- Create training courses in the document control system and coordinate and schedule training sessions.
- Monitor and maintain employee training groups.
- Periodically review external standards, obtain new standards, and coordinate impact reviews.
- Maintain standards log.
- Maintain Device Master Records (DMR).
- Perform audits or aid in performing or gathering data for audits.
- Collect data for reports and presentations.
- Train all new or promoted management-level employees on the document control system.
- Quality and Document Control Software Administrator.
- Scan documents using scanning equipment.
- Maintain electronic and hard copy Device History Records (DHR).
- Maintain awareness of workplace safety and relevant training.
- May provide direction to Documentation Control employees.
- Support company quality systems and adhere to FDA and ISO regulations for Medical Devices.
- Support and comply with the company Quality System, ISO, and medical device requirements.
- Read, understand, and follow work instructions and standard work.
Requirements:
- 2-year Vocational/Technical School degree (or equivalent of education).
- 2-3 years of experience.
- English language (reading and writing).
- Experience with general office equipment, such as copiers, printers, fax machines, and scanners.
- Reliable and self-motivated.
- Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
- Clear and effective verbal and written communication skills.
- Attention to detail.
- Organizational skills.
- Minimal supervision.
- Ability to work in a fast-paced team environment.
What We Offer:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A comprehensive benefits package, including medical, dental, vision, and life insurance options.
- A 401(k) retirement plan and profit-sharing retirement plan.
- Paid time off and short-term disability and long-term disability insurance.
- Free parking, annual picnic, holiday party, volunteer opportunities, training and development opportunities, tuition reimbursement, and annual flu vaccination clinics.
Join our team of dedicated professionals and contribute to the success of Quality Tech Services, LLC.
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