Document Control Coordinator

Precision One Medical, Inc.; Oceanside (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

Precision One Medical, Inc. seeks an experienced Document Control Specialist to uphold the Quality Management System and manage the company document control process.

This role ensures controlled documentation is reviewed, approved, and properly stored across digital and physical records. The ideal candidate will have 3+ years in a medical device setting, knowledge of ISO standards, and strong communication skills to coordinate with engineering and production teams.

Qualifications

• Proficient with ISO13485 and 21 CFR Part 820/11
• Solid understanding of QSR ISO 14971
• Basic blueprint reading (GD&T)
• Basic measurement instrument skills (micrometers, calipers)
• Ability to adapt to changes and meet deadlines
• Strong written and verbal communication
• Detail-oriented and independent decision-maker
• Collaborates effectively with cross-functional teams

Responsibilities

• Maintain and improve the document control system per procedures
• Manage Change Control Board (CCB) and document processing tasks
• Prepare, process, and distribute quality manufacturing documents
• Oversee document storage and retrieval for hardcopy/electronic records
• Review and maintain device history records and inspection plans
• Support nonconforming materials (MRB) activities
• Coordinate with engineering to meet production schedules with complete documentation
• Manage company training program to meet regulatory requirements
• Identify continuous improvement opportunities for document control processes

Skills

ISO13485

21 CFR Part 820

Part 11

Quality system regulations

GD&T

Measuring instruments

Strong communication

Independent judgment

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

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

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

Handling (grasping, holding)

Automatic Trans

Repetitive Motion - Hands

Standard Trans

Repetitive Motion - Feet

Monday-Thursday 5:30 am - 3:30 pm