Document Control Coordinator

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Adhere to the Company's Quality Management System to ensure compliance with applicable regulatory requirements.
• Establish, document, conduct, and maintain the company document control system, including but not limited to document approval, distribution, changes, and storage/retrieval
• Ensure all controlled documentation is reviewed and completed per established procedures and requirements
• Manage the Change Control Board (CCB) and any tasks associated with the processing of controlled documentation
• Manage the preparation, processing, and distribution of quality manufacturing documentation
• Manage and maintain the storage system for all hardcopy and electronic records, including the organization and numbering of quality system documentation
• Inspect device components and finished devices per established inspection procedures
• Maintain and create new inspection plans as required
• Review and maintain completed device history records
• Support the nonconforming materials system, including material review board (MRB) efforts
• Coordinate activities with engineering and other departments to ensure production schedules are met by ensuring appropriate documentation is complete and ready
• Manage the company training program, ensuring that applicable requirements are met in a timely manner
• Identify and drive continuous improvement opportunities related to document control processes
• Maintain the integrity of all applicable quality documents and records
• Provide ongoing communication and regular status updates to senior management team
• Interface and collaborate with other departments, outside vendors, stakeholders, etc.
• Perform other duties as required

SUPERVISORY RESPONSIBILITIES

Direct Reports: Yes N/A

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Proficient knowledge of ISO13485 and 21 CFR Part 820, Part 11
• Proficient knowledge of Quality System Regulations ISO 14971
• Basic blueprint reading (GD&T)
• Basic skill with precision measuring instruments (e.g. micrometers, calipers, gauges, optical comparators, etc.)
• Must be flexible and able to adapt to change
• Strong written and verbal communication skills
• Highly detail-oriented
• Must be able to exercise independent judgment and discretion
• Communicates and works well with employees of all positions
• Project collaboration experience involving external stakeholders
• Computer literacy with standard software applications

EDUCATION AND/OR EXPERIENCE

• Bachelor's degree or equivalent experience required
• 3+ years of experience in a medical device manufacturing environment

CERTIFICATES, LICENSES, REGISTRATIONS

• N/A

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• The work environment is an industrial setting dedicated to the production and assembly of medical devices that utilize machinery, equipment, and specialized processes to transform raw materials into finished products. The work environment also includes a typical office setting.

PHYSICAL DEMANDS

Analysis of Physical Demands

N = Never

R = Rarely Less than 1 hour per week

O = Occasional 1% to 33% of time

F = Frequent 34% to 66% of time

C = Constant over 66% of time

Activity

Frequency

Activity

Frequency

Lifting/Carrying

N

R

O

F

C

Twisting/Turning

N

R

O

F

C

Under 10 lbs

Reach over shoulder

11-20 lbs

Reach over head

21-50 lb

Reach outward

51-100 lbs

Climb

Over 100 lbs

Crawl

Pushing/Pulling

N

R

O

F

C

Kneel

Under 10 lbs

Squat

11-20 lbs

Sit

21-50 lbs

Walk-Normal Surfaces

51-100 lbs

Walk-Uneven Surfaces

Over 100 lbs

Walk-Slippery Surfaces

Other

N

R

O

F

C

Stand

Keyboard/Ten Key

Bend

Fingering (fine dexterity)

Driving

N

R

O

F

C

Handling (grasping, holding)

Automatic Trans

Repetitive Motion - Hands

Standard Trans

Repetitive Motion - Feet