Quality Specialist

ARCHAthol, MA
Onsite

About The Position

The Quality Specialist reports directly to the Director of Operations and is responsible for supporting and maintaining the company's Quality Management System (QMS) while ensuring product quality, accuracy, and compliance with ISO 9001 standards, customer requirements, and internal procedures. This position plays a key role in driving continuous improvement, supporting manufacturing operations, and fostering a culture of quality throughout the organization.

Requirements

  • Working knowledge of Quality Management Systems.
  • Strong understanding of Geometric Dimensioning and Tolerancing (GD&T).
  • Ability to read, interpret, and evaluate mechanical drawings, specifications, inspection instructions, and quality requirements.
  • Ability to determine product conformity based on engineering and customer documentation.
  • Strong analytical, problem-solving, and organizational skills.
  • Effective verbal and written communication skills.
  • Ability to work independently while managing multiple priorities in a fast-paced manufacturing environment.
  • Proficiency with Microsoft Office and quality-related documentation systems.
  • Ability to interact professionally and respectfully with employees at all levels of the organization.

Nice To Haves

  • Experience managing a calibration program and performing equipment calibration.
  • Experience with corrective action systems, root cause analysis methodologies, and continuous improvement tools.
  • Experience in manufacturing, machining, metal fabrication, or precision manufacturing environments.
  • Familiarity with ERP systems and document control software.

Responsibilities

  • Ensure adherence to Quality Management System (QMS) requirements in accordance with ISO 9001 standards and company procedures.
  • Promote quality awareness across all departments and reinforce regulatory and customer requirements.
  • Maintain a visible and active presence on the manufacturing floor to support quality initiatives and process compliance.
  • Coordinate and facilitate Material Review Board (MRB) activities, including documentation and disposition of nonconforming material.
  • Perform and support process capability studies to meet customer and internal requirements.
  • Assist in the preparation, execution, and documentation of Installation Qualification (IQ) and Operational Qualification (OQ) activities for new and revised equipment.
  • Lead and support investigations, root cause analyses, and corrective and preventive action (CAPA) activities for internal and customer-related quality issues.
  • Collect, analyze, and report quality metrics to support customer requirements and management review activities.
  • Assist with employee training programs related to quality standards, procedures, and technical requirements.
  • Administer and maintain the equipment calibration system, including scheduling, tracking, and documentation.
  • Serve as a backup for final inspection activities as needed.
  • Manage quality documentation, including document control, revision management, filing structures, and electronic record retention.
  • Maintain ownership of assigned document pathways, folders, and controlled records.
  • Provide support and backup coverage for purchasing and order entry functions as required.
  • Support continuous improvement initiatives throughout the organization.
  • Maintain a safe, clean, and organized work environment.
  • Perform other duties and special projects as assigned.
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