Document Control Supervisor

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

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

Monitor team productivity and provide constructive feedback

Manage team workflow and align performance expectations with company goals

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

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 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 accommodations 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 utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. The work environment also includes a typical office setting.

This position is based onsite and requires regular in-person attendance at the company's facility

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