QMS Specialist

Rexa, Inc.•Middleborough, MA

20h•$54,000 - $68,000•Onsite

About The Position

The ISO 9001 QMS Specialist helps keep our Quality Management System organized, current, and audit-ready. This role works with production, engineering, supply chain, customer support, and leadership to make sure procedures, records, audits, training, and improvement activities are clear, accurate, and effective.

Requirements

Associate degree in quality, engineering technology, manufacturing, operations, industrial technology, business, or a related field preferred.
Equivalent manufacturing quality experience may be considered.
At least 3 years of experience supporting a quality management system in a manufacturing, assembly, fabrication, machining, electronics, industrial, or regulated production environment.
Working knowledge of ISO 9001 requirements and quality management system processes.
Experience with internal audits, document control, corrective action, nonconforming product control, inspection records, calibration, and continual improvement.
Ability to read and understand procedures, work instructions, records, and manufacturing documentation.
Strong written and verbal communication skills.
Ability to work well with production employees, supervisors, engineers, managers, suppliers, customers, and auditors.
Strong organization, follow-up, and documentation skills.
Comfortable using Microsoft Office and related business systems such as document management, ERP, MRP, MES, calibration, inspection, or QMS software.

Nice To Haves

ISO 9001 Internal Auditor or Lead Auditor certification.
ASQ membership or ASQ certifications such as Certified Quality Auditor or Certified Quality Improvement Associate.
Experience with Lean, Six Sigma, 5 Whys, fishbone diagrams, Pareto analysis, process mapping, FMEA, control plans, mistake-proofing, or other problem-solving tools.
Familiarity with manufacturing drawings, specifications, bills of material, routers, work instructions, production travelers, inspection plans, measurement systems, and traceability requirements.
Experience with customer, supplier, regulatory, or industry-specific quality requirements.

Responsibilities

Maintain and improve ISO 9001 QMS documents, including procedures, work instructions, forms, inspection records, production records, and controlled documents.
Coordinate QMS document control by processing change notices and keeping electronic files and production binders up to date.
Plan, conduct, and document internal audits of manufacturing and support processes.
Track QMS training to help ensure employees are trained on the procedures that apply to their work.
Support ISO 9001 certification, surveillance, customer, supplier, and regulatory audits.
Work with process owners to document, measure, and improve manufacturing and support processes.
Compile audit results, quality metrics, customer feedback, supplier performance, nonconformities, risks, opportunities, and improvement activities for management review.
Coach employees on QMS procedures, document control, audit readiness, nonconforming product handling, and quality best practices.