Documentation Specialist

4 weeks ago

Minneapolis, United States Quality Tech Services, LLC Full time

Overview:

Company Overview

Quality Tech Services, LLC. is a Cretex Medical Company that is a fast-growing dynamic leader within the Twin Cities medical device industry. QTS offers a technical service to assist medical device OEMs throughout the nation with cleanroom assembly and packaging operations. As an employee at QTS, you'll enjoy a culture founded on teamwork, respectful communication, creative problem solving, dependable follow through and excellent customer service.

Responsibilities:

Documentation Specialist Ideal Candidate Profile

QTS is currently seeking an energetic, responsive and well-organized full-time Documentation Specialist that will be responsible for coordinating all phases of document control, verification of documentation control requirements and maintenance of various files, records, and logs. It will also maintain document control related processes and document retrieval support for audits.

Documentation Specialist Job Summary

  • 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.
  • Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance.


Qualifications:

Documentation Specialist Skills and Experience

  • 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 Is It Like to Work for QTS?

At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS:

  • "I would describe my coworkers as kind and friendly."
  • "... I interned at QTS, then I went back to school... I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going"
  • "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun"

We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.

QTS Benefits:

As a Cretex Medical company, QTS offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. You are also automatically enrolled in Cretex's 401(k) retirement plan and the Cretex Profit Sharing Retirement Plan and are eligible for paid time off and short-term disability and long-term disability insurance.

QTS also offers company specific benefits, such as:

  • Free Parking
  • Annual Picnic
  • Holiday Party
  • Volunteer Opportunities
  • Training and Development opportunities
  • Tuition Reimbursement
  • Annual Flu Vaccination Clinics

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