Supports document control, training administration, and routine eQMS administration under the direction of the Quality Systems Manager. Maintains accurate, traceable records and follows approved procedures supporting

ISO 13485

2016, FDA

QMSR, 21 CFR

Part 11, and applicable Computer Software Assurance (CSA) activities. Administrative access is limited to trained and authorized responsibilities.

Essential Duties and Responsibilities:

Coordinate document creation, revision, review, approval routing, release, and obsolescence through approved processes. Check documents for correct formatting, numbering, revision information, required fields, and completeness. Administer approved training assignments, maintain training records, and follow up on overdue training. Process eQMS support tickets; document authorization, actions taken, resolution, and supporting evidence. Perform authorized routine access updates, group and library maintenance, and record owner reassignments within assigned permissions. Implement approved administrative corrections while preserving record history and required traceability. Assist users with document, training, and routine access issues; escalate issues outside assigned authority. Support audits, record retrieval, reporting, and assigned CSA testing or verification activities. Protect electronic records, signatures, and audit trails. Do not sign for others, bypass approvals, or independently change validated workflows. Complete assigned QMS activities, including CAPA actions and change management tasks, following approved procedures, meeting assigned deadlines, and documenting completion evidence Serve as a QMS liaison (within limitation) under the Quality Systems Manager's direction by coordinating assigned activities with departments, tracking progress, and escalating delays or compliance concerns. To perform this job successfully, an individual should demonstrate the following competencies: List at least 5 competencies and definition of competencies:

Organization:

Tracks assignments, priorities, and deadlines.

Communication:

Gives clear guidance and follows up respectfully.

Accountability:

Works within authorized responsibilities and escalates concerns.

Continuous Improvement:

Identifies practical ways to improve document and administrative processes. QMS Knowledge and Compliance

• Understands and applies approved QMS procedures supporting

ISO 13485

2016 and

FDA QMSR

; completes assigned activities accurately, maintains traceable evidence, and recognizes when guidance or approval is needed. CSA Awareness

• Understands basic software assurance, follows approved admin procedures, records checks performed, and escalates changes requiring review. Attention to Detail
• Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently. Problem Solving
• Builds a logical approach to address problems or opportunities or manage the situation at hand by drawing on one's knowledge and experience base and calling on other references and resources, as necessary. Discernment/Judgement
• Makes decisions authoritatively and wisely, after adequately contemplating various available courses of action. Communication (Oral and Written)
• Effectively transfers thoughts and expresses ideas orally or verbally in individual or group situations. Drive for Results
• Demonstrates concern for achieving or surpassing results against an internal or external standard of excellence. Shows a passion for improving the delivery of services with a commitment to continuous improvement. Initiative
• Does more than is required or expected in the job; does things that no one has requested that will improve or enhance products and services, avoid problems, or develop entrepreneurial opportunities.

Plans ahead for upcoming problems or opportunities and takes appropriate action.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individual's disabilities to perform the essential functions. Education and/or

Experience:

Demonstrated experience in document control, training administration, and routine eQMS administration. Hands-on experience processing support requests, routing documents, and maintaining controlled records. Relevant experience and demonstrated ability are the primary selection factors. A degree is not required. Preferred Education and/or

Experience:

Experience in medical devices, life sciences, or another regulated industry. Experience with ComplianceQuest or a comparable eQMS. Familiarity with

ISO 13485

2016, QMSR, 21 CFR Part 11, and risk-based CSA activities. A degree in quality, life sciences, information systems, or a related field is a plus

Skills and Knowledge Requirements:

Strong proofreading, recordkeeping, and organizational skills. Understanding of document revisions, approval workflows, training records, and access controls. Ability to follow procedures, retain evidence, and recognize when additional approval is required. Proficiency with Microsoft Office and electronic tracking tools. Clear written communication and effective user support