Document Control & Quality Systems Coordinator

About VORTRAN Medical

VORTRAN Medical Technology 1, Inc. is a Sacramento-based medical device manufacturer specializing in respiratory medical devices. We operate under an ISO 13485 Quality Management System and manufacture products for domestic and international markets.

We are seeking a highly organized and detail-oriented Document Control & Quality Systems Coordinator to support our Quality Management System and day-to-day document control activities.

This is a hands-on document control and quality systems administrative position. It is not an engineering position. The ideal candidate will have previous experience working with controlled documentation in a medical device, pharmaceutical, aerospace, manufacturing, or other regulated environment.

The position is available immediately, and the selected candidate will have an opportunity to train directly with the current employee during the transition period.

Primary Responsibilities

The Document Control & Quality Systems Coordinator will be responsible for maintaining accurate, current, and traceable company quality records and controlled documentation.

Responsibilities include:

● Maintain and organize controlled Quality Management System documents, including SOPs, procedures, work instructions, forms, and records.

● Process document revisions and ensure obsolete documents are properly removed or archived.

● Maintain document revision history and ensure appropriate approvals are obtained before documents are released.

● Maintain employee training records and assist with tracking required training when procedures or responsibilities change.

● Distribute updated procedures and controlled documents to appropriate personnel.

● Maintain calibration records, equipment logs, certificates, and calibration schedules.

● Track upcoming calibration due dates and coordinate required documentation.

● Maintain quality records and assist with proper filing, retention, and retrieval of records.

● Assist with Device History Records and other manufacturing/production documentation as needed.

● Assist Operations and Quality/Regulatory personnel with preparation for internal, external, ISO, FDA, and other regulatory audits.

● Assist with maintaining audit records, corrective action documentation, and other Quality Management System records.

● Maintain organized electronic and physical document filing systems.

● Ensure documents are complete, legible, properly approved, and readily retrievable.

● Assist with document and record requests from management, auditors, regulatory personnel, and other departments.

● Maintain trackers, logs, spreadsheets, and other administrative quality-system records.

● Follow established company procedures and ISO 13485 document-control requirements.

● Identify missing, incomplete, outdated, or inconsistent documentation and escalate issues to the appropriate manager.

● Perform other document control, quality system, and administrative duties as assigned.

Qualifications

Required

● Strong attention to detail and organizational skills.

● Ability to accurately maintain documents, records, spreadsheets, and filing systems.

● Strong Microsoft Word, Excel, Outlook, and general computer skills.

● Ability to read and follow written procedures and work instructions.

● Strong written and verbal communication skills.

● Ability to manage multiple deadlines and recurring tasks.

● Ability to work independently while communicating issues appropriately.

● Ability to maintain confidentiality and handle controlled company information.

● High school diploma or equivalent.

Preferred

● 1–3+ years of experience in Document Control, Quality Assurance Administration, Quality Systems, Records Management, or a similar position.

● Experience working in a medical device, pharmaceutical, aerospace, biotechnology, or regulated manufacturing environment.

● Familiarity with ISO 13485.

● Familiarity with FDA-regulated Quality Management Systems.

● Experience with controlled SOPs, work instructions, forms, training records, calibration records, and document revision control.

● Experience supporting internal or external audits.

● Experience maintaining manufacturing or Device History Records.

● Associate’s or bachelor’s degree in a related field is helpful but not required when equivalent relevant experience is available.

Ideal Candidate

We are particularly interested in someone who has already worked in an environment where documentation must be controlled, traceable, accurate, and audit-ready.

The successful candidate should be comfortable taking ownership of recurring document-control responsibilities while knowing when an issue needs to be escalated to Operations, Quality, Regulatory, or management.

This role may be a particularly good fit for someone currently working as a:

● Document Control Coordinator

● Document Control Specialist

● Quality Assurance Coordinator

● Quality Systems Coordinator

● Quality Administrator

● QA Administrative Assistant

● Regulatory/Quality Coordinator

● Medical Device Documentation Specialist

What Success Looks Like

The successful candidate will help ensure that:

● Current procedures and forms are readily available.

● Obsolete documents are appropriately controlled.

● Training records are current and traceable.

● Calibration records and due dates are properly maintained.

● Quality records are organized and retrievable.

● Documentation is maintained in an audit-ready condition.

● Quality-system administrative tasks are completed accurately and on schedule.

VORTRAN Medical Technology 1, Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to characteristics protected by applicable federal, state, or local law.

Pay: $20.00 - $24.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Work Location: In person