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