Document Control Coordinator

RiseMe; California (MO); On-site; USD 65,000 - 90,000; Full time

Job summary

RiseMe seeks a quality/document control specialist to ensure regulatory compliance and maintain the document control system. You will manage approvals, distribution, and storage of quality documents, coordinate with engineering, and support MRB and nonconforming materials processes. Strong attention to detail and independent judgment are essential.

Qualifications

• Bachelor’s degree or equivalent experience required.
• 3+ years of experience in a medical device manufacturing environment.
• Proficient knowledge of ISO13485 and 21 CFR Part 820, Part 11.
• Strong written and verbal communication skills.
• Highly detail-oriented and able to exercise independent judgment.

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 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 tasks associated with processing of controlled documentation
• Coordinate activities with engineering and other departments to ensure production schedules are met by ensuring appropriate documentation is complete and ready
• Maintain the integrity of all applicable quality documents and records
• Provide ongoing communication and regular status updates to senior management team

Skills

ISO13485 knowledge

21 CFR Part 820

Part 11 familiarity

Strong communication

Detail-oriented

Independent judgment

Cross-functional collaboration

Computer literacy

Education

Bachelor’s degree or equivalent

Tools

Micrometers

Calipers

Gauges

Optical comparators

Job description

ESSENTIALDUTIESANDRESPONSIBILITIES

• 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

Direct Reports: Yes N/A

SUPERVISORY RESPONSIBILITIES

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 = RarelyLess than 1 hour per week
O = Occasional1% to 33% of time
F = Frequent34% to 66% of time
C = Constantover 66% of time
Activity
Frequency
Activity
Frequency
Activity
Frequency
Activity
Frequency
Activity
Frequency
Under 10 lbs
Activity
Lifting/Carrying
Frequency
R
O
Activity
Twisting/Turning
Frequency
R
O
F
Activity
Reach over shoulder
Frequency
O
F
O
Activity
Reach over head
Frequency
O
F
F
Activity
Reach outward
Frequency
O
F
O
F
O
F
Activity
Climb
Frequency
F
F
Activity
Crawl
Frequency
F
F
Activity
Pushing/Pulling
Frequency
N
O
F
F
Activity
Kn ...
Tw ...
...

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