Document Control & Quality Systems Specialist

Document Control & Regulatory Compliance Coordinator

Location: Beverly, MA

Pay: $60,000–$65,000

Job Type: Direct Hire

Please Note: This is an engineering and manufacturing-focused document control role. Candidates whose experience is primarily in pharmaceutical, biotechnology, or medical device industries are not the target profile for this position.

Harmonic Drive LLC is seeking a Document Control & Regulatory Compliance Coordinator to support Engineering, Manufacturing, Quality, and Operations by maintaining controlled documentation, administering Quality Management System (QMS) processes, and ensuring compliance with company and industry standards.

This role is best suited for candidates with experience in industrial, aerospace, defense, robotics, motion control, precision machining, electronics, or other discrete manufacturing environments
.

• Maintain engineering, manufacturing, quality, and operations documentation in accordance with the company QMS.
• Coordinate document revisions, engineering change orders (ECO/ECN), and document release processes.
• Create and maintain document templates, work instructions, forms, and controlled procedures.
• Maintain QMS documentation, employee training records, and document review schedules.
• Support Engineering, Manufacturing, and Quality teams with document control improvements.
• Assist with internal, customer, supplier, and certification audits.
• Maintain compliance documentation for AS9100, ISO 9001, REACH, RoHS, TSCA, Prop 65, and CMRT requirements.
• Support corrective actions, quality records, and regulatory documentation.

• 3+ years of document control or quality systems experience in a manufacturing environment.
• Experience supporting Engineering, Manufacturing, or Quality departments.
• Experience working within an AS9100 and/or ISO 9001 Quality Management System.
• Experience with engineering change control (ECO/ECN) and controlled documentation.
• Experience writing and maintaining SOPs, work instructions, technical procedures, and forms
  .
• Proficient with Microsoft Office and electronic document control/QMS software.
• Strong organizational, communication, and documentation skills.

• QMS software such as Windchill, Arena, Master Control, Documentum, or Share Point .
• Knowledge of BOMs, configuration management, CAPA, internal audits, and supplier quality documentation
  .

Candidates should come from industrial or discrete manufacturing environments, including: