Document Control Technician

ABOUT THE JOB

The primary functions include performing routine or repetitive application of standard policies and processes within Lincotek Medical. Ensures appropriate documentation and records are available and accessible to the production floor, as needed by production. Basic understanding of inspection tools, CNC machining and finishing processes.

MAIN RESPONSIBILITIES:

To perform this job successfully, an individual must be able to perform each of the Major Responsibilities, including the following:

• Coordinates and updates the company training program.
• Requires the ability to learn and meet established department specific work instructions and procedures.

• Ensures compliance, timeliness, and accuracy of routing and supporting documentation to customer specification. Authorized to correct as necessary.
• Maintains the documentation files in compliance with ISO 13485: 2016 and 21 CFR Part 820.
• Creates, maintains and improves controls on all documentation masters, device history records and files.

• Other duties as assigned.

EDUCATION AND/OR EXPERIENCE:

High School diploma, or equivalent required. Proven capability and demonstrated record of performance in a technician equivalent role. Prefer less than one year of experience.

SKILLS:

LANGUAGE SKILLS:

• Ability to read and interpret documents such as safety rules.
• Ability to write routine correspondence.

MATHEMATICAL SKILLS

• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

REASONING ABILITY:

• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

WORK ENVIRONMENT:

This job operates in both an office environment and a manufacturing environment. The role routinely uses standard office equipment, such as computes, phones, photocopiers, filing cabinets and fax machines. The individual will be required to adhere to safety policies and procedures on the manufacturing floor.

PHYSICAL DEMAND:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, use hands to finger, handle or feel and reach with hands and arms.

The employee is occasionally required to sit, climb or balance and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 lbs and occasionally lift and or move up to 50 lbs. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Lincotek Medical provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.