QMS Specialist

Flexcon•Spencer, MA

62d

About The Position

The QMS Specialist serves as the primary administrator and subject matter expert for the organization’s Quality Management System (QMS) in alignment with ISO 9001, ensuring ongoing compliance, effectiveness, and integration across business operations. This role leads document control, audit coordination, corrective and preventive action processes, and QMS performance reporting while serving as the subject matter expert for quality standards and requirements. The QMS Specialist partners with cross-functional teams to support audits, management review, training, change management, and continuous improvement initiatives that drive consistency, compliance, and customer satisfaction.

Requirements

Bachelor’s degree (technical degree preferred)
3-5 years experience with ISO and formal ISO 9001 training is a plus
Basic knowledge of quality in a manufacturing setting preferred
Experience integrating QMS across an organization is preferred
Strong project management skills
Excellent communication and teamwork skills to collaborate effectively with diverse teams.
Familiarity with manufacturing industry-specific standards and regulations.

Responsibilities

Serves as the primary administrator and subject matter expert for the organization’s Quality Management System (QMS) in alignment with ISO 9001 requirements, ensuring ongoing compliance and effectiveness.
Control and administer all QMS documentation, including procedures, work instructions, forms, and records, ensuring accuracy, version control, and accessibility.
Lead the document control process, including creation, review, approval, revision, distribution, and archival of quality documents.
Ensure QMS processes are effectively integrated across departments and aligned with business operations.
Monitor and maintain compliance to internal procedures, customer requirements, and applicable regulatory or industry standards.
Coordinate and support internal audits, including audit scheduling, auditor training, execution, reporting, and follow-up of corrective actions.
Run the ISO audits with external auditing organization.
Support management review activities by compiling data, tracking action items, and ensuring timely follow-up.
Train employees on QMS processes, document control requirements, and ISO 9001 awareness.
Support a culture of continuous improvement by identifying process gaps, standardization opportunities, and best practices.
Act as the subject matter expert for QMS-related questions and provide guidance to cross-functional teams.
Provide recommendations on systems and utilization of QMS documentation.
Support change management activities to ensure QMS impacts are assessed and documented when processes or systems change.