Quality Systems Analyst

• Employee Type Full Time Exempt

The Quality Systems Analyst administers the quality management system for an assigned area, including the ISO 9001 internal audit program, calibration control, document and change control, and the facility 5S program. This role monitors quality system compliance, reports audit and calibration performance to the QMS Manager, leads root cause and corrective action activity for recurring failures, and directs in-process quality control (IPQC) auditors to ensure product and process conformity.

Manage and perform the ISO 9001 internal audit program for the assigned area, including audit scheduling, execution, findings documentation, and follow-up to closure.

Manage and perform the facility 5S program for the assigned area.

Manage QMN calibration records for the assigned area and monitor calibration schedules to prevent lapses in equipment status.

Manage and enforce all aspects of change management and deviation control, including documentation, approval routing, and closure.

Supervise IPQC auditors, assign daily audit coverage, and report out on IPQC audit results daily.

Report on audit and calibration failures and lead the team through root cause analysis (RCA) and corrective and preventive actions (CAPA) for recurring failures.

Generate weekly detail and summary reports and charts to support the QMS Manager.

Track and trend quality metrics for the assigned area and elevate adverse trends to the QMS Manager.

Maintain quality system documentation and records in a controlled, audit-ready condition.

Support external, customer, and certification body audits by preparing records and responding to auditor requests.

Recommend modifications to existing quality or production standards to achieve optimum quality within the limits of process capability.

Train production and quality personnel on quality system procedures, audit expectations, and documentation standards.

Assist the Human Resources department with document and procedure creation for the assigned building.

Act as backup and liaison to the Quality Supervisors, Quality Managers, and QMS Manager as needed.

Complete special projects as assigned in support of ISO 9001, ISO 27001, and quality management system initiatives.

Other duties as assigned.

Bachelor’s degree in Quality, Engineering, or Management; or equivalent combination of education and experience.

Minimum 6 months to 1 year of experience leading a team or serving in a supervisory capacity.

Experience working within an ISO 9001 quality management system; exposure to ISO 27001 preferred.

Working knowledge of internal auditing, calibration control, and corrective action methodology preferred.

This is a FULLY ONSITE position; must be able to report onsite daily.

Available to work overtime as needed, including weekends, public holidays, and evenings.

Ability to work in a multi-cultural environment with multiple languages spoken.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer literate in a Windows environment, including Excel, Word, PowerPoint, Visio, and Edge.

Detail oriented with strong analytical and organizational skills.

Strong interpersonal skills with the ability to use tact and diplomacy.

Self-motivated with the ability to work independently under minimal supervision and as part of a team.

Ability to operate independently across office, manufacturing, and warehouse areas.

Ability to maintain confidentiality and handle sensitive information professionally.

Work is performed in office, manufacturing, and warehouse environments; temperatures are controlled but occasionally can be warmer or colder…