Quality Systems Specialist

Job Description

Job Description

SUMMARY

The Quality Systems and Competence Specialist is responsible for the administration, maintenance, and continuous improvement of the Quality Management System (QMS) with primary ownership of document control, document review and release processes, and the training and competence management system. This role ensures compliance with internal procedures, customer requirements, and applicable regulatory and quality standards by maintaining accurate documentation, ensuring employee competency through effective training systems, and supporting audits and continuous improvement initiatives.

ESSENTIAL JOB FUNCTIONS

• Administer and maintain the Document Review system, ensuring controlled documents are properly reviewed, approved, released, revised, and archived in accordance with company procedures.
• Coordinate document reviews with process owners, subject matter experts, and management to ensure timely updates and regulatory compliance.
• Ensure obsolete or superseded documents are removed from points of use.
• Maintain document templates, numbering systems, and formatting standards across the Quality Management System.
• Serve as system administrator for the training and competence management system, including course assignments, tracking, reporting, and record retention.
• Coordinate new hire, job-specific, and refresher training requirements to ensure employees are qualified for their assigned responsibilities.
• Monitor training effectiveness and competency through assessments, evaluations, or other defined methods.
• Generate and analyze training and document metrics (e.g., overdue reviews, training completion rates, time to competency) and report status to management.
• Support internal, customer, and third-party audits by providing QMS documentation, training records, and system evidence.
• Assist in the development, maintenance, and improvement of quality procedures related to document control, training, and competence.
• Support continuous improvement initiatives related to quality systems, compliance, and operational efficiency.
• Collaborate cross-functionally with Engineering, Operations, HR, and Management to ensure alignment of documentation and training requirements.
• Other duties as required in support of the department and the company.

SUPERVISOR RESPONSIBILITIES

This role does not include direct supervisory responsibility for other employees. However, it provides opportunities for professional growth and advancement.

QUALIFICATIONS

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

EDUCATION AND EXPERIENCE

• High School Diploma or GED required; Associate's degree preferred.

• 35 years of experience in quality systems, document control, training administration, or related quality roles in a manufacturing or regulated environment.
• Previous experience supporting audits and regulatory compliance preferred.

LANGUAGE REQUIREMENTS

• Excellent verbal and written communication skills in English.

QUALIFICATIONS

• Strong working knowledge of Quality Management Systems and document control principles.
• Experience with electronic document management and training systems.
• Working knowledge of ISO 9001, AS9100, ISO 13485, or similar quality standards preferred.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines in a regulated environment.
• Effective written and verbal communication skills.
• Proficient in Microsoft Office applications (Word, Excel, Outlook).
• Ability to work independently and collaboratively across departments

EXPORT COMPLIANCE DISCLAIMER

This position includes access or potential access to ITAR and EAR (Export Administration Regulations) technical data. Therefore, candidates must qualify as US Persons, defined as US Citizens or Permanent Residents (Green Card Holders).

TRAVEL

Approximately <5% of travel is expected.