Document Control Technician

Job Title: Document Control Technician

Department: BU110 – Quality

Status: Full-Time Non-Exempt

Reporting To: Quality Supervisor/Quality Manager

Position Purpose:

The Document Control Technician assists the Quality Supervisor/Quality Manager to produce, distribute, control, and archive controlled documents in conjunction with the Document Control Specialist. This position is responsible for ensuring that quality documentation and records follow internal requirements as well as ISO 13485 and applicable FDA requirements.

Responsibilities:

• Follow ISO 13485 and applicable FDA required document practices
• Assist in maintaining HMS quality systems, supporting documentation and record keeping
• Assists in Change Order process for routing, reviewing, and completion for all HMS quality systems
• Track change orders in the document control system (ISOXpress)
• Review document formatting, spelling, and content
• Assist with HMS document numbering system
• Own and maintain the archive database and document control room
• Assist in completion of lot specific records, filing and storage requirements
• Assist and perform excel validations as required
• Assist in data entry and evaluation if needed
• Scan all documents into HMS database and appropriately file within the Quality network location
• Support external audits initiated by customers and regulatory agencies, and internal audits
• Support and/or perform other duties as required

Education, Qualifications & Experience:

• Associates degree in technical discipline or equivalent education
• Minimum of 1-year experience working in the medical device industry preferred
• Demonstrates document control experience in the medical device industry
• Ability to read and follow Quality policies, procedures, and work instructions for job tasks
• Integrity and high ethical standards
• Computer competency in MS Office – Word, Excel and Outlook
• Excellent verbal, interpersonal and written communication skills
• Attention to detail and organizational skills
• Self-starter, and motivated individual who works independently
• Desire to learn and grow with the company
• Minimally, understand and apply knowledge of ISO 13485: 2016 and ISO 17025: 2017

Authority:

• To ensure the effectiveness of laboratory activities
• To report to laboratory management on performance of the Quality Management System, and any need for improvement
• The laboratory staff shall be committed to impartiality and confidentiality, including not allowing commercial, financial, and other pressures to compromise impartiality

Working Conditions and Health & Safety:

• Manual dexterity
• Ability to lift 40 lbs.
• Heated and air-conditioned office environment
• ISO Class 7 Cleanroom Environment
• Laboratory
• Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space

Harland Medical System’s commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System’s internal procedures, where deemed appropriate per assigned job functions.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit and stand for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist.

Pay: $22.00 - $25.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Parental leave
• Vision insurance

Education:

• Associate (Preferred)

Experience:

• Document management: 1 year (Preferred)
• ISO 13485: 1 year (Preferred)

Ability to Commute:

• Eden Prairie, MN 55344 (Preferred)

Work Location: In person

Salary : $22 - $25