Document Control and Regulatory Compliance Coordinator

Harmonic Drive L.L.C. • Beverly, MA

9h • $60,000 - $65,000 • Hybrid

About The Position

Responsible for creation, organization, control, and maintenance of various core processes documentation (Engineering, Quality, and other Operations) in accordance with the company Quality Management System (QMS) procedures and policies. Regulatory Compliance will support the organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.

Requirements

• Experience with AS9100 / ISO9001 document control quality management system.
• Copy Exact / process control knowledge.
• Sound computer skills and proficient in Microsoft Office suite.
• Experience with writing quality and other technical procedures and forms.
• Understanding of workflows to be a QMS software or applications administrator.
• Give or provide training in various procedures.
• Assist in various quality and customer audits.
• Knowledge of regulatory requirements such as REACH, RoHS, CMRT, Prop 65, TSCA and others.
• Ability to communicate effectively both verbally and written in English.
• Bachelor’s degree required or equivalent experience.
• Candidates are required to provide proof of either US citizenship, Permanent US residency or classification as a protected individual as defined in 8 USC 1324b (a) (3).

Responsibilities

• Assist Engineering, Operations, Manufacturing Engineering, and Quality with document control and improvements.
• Oversee document change process.
• Create and maintain document control workflows in the internal Document Control software or applications.
• Create and maintain forms and document templates.
• Assist in QMS internal and external audits and other documentation compliance requirements and registration.
• Maintain employee training records, reports and requirements in the training database.
• Provide scheduled notifications of pending or past due trainings and document review.
• Prepares or maintains QMS (Quality Management Systems: ISO) files and related documentation.
• Assist in updating internal company applications Return Material Authorization and other Quality and Engineering applications as needed.
• Ensure regulatory requests are submitted on the regulatory app.
• Assist, coordinate or prepare US and international regulatory submissions.
• Prepare or coordinate responses as requested by regulatory agencies, customers, suppliers and internal processes.
• Reviews quality protocols to ensure appropriate collection of data to fulfill regulatory requirements.
• Ensure all QMS procedures, work instructions (WI), forms and policies and related documents are in compliance with the QMS requirements and other Industry standards.
• Monitor and follow-up action items of Quality related Apps: Regulatory Requirements, Deficiency or Defective Reports, Corrective Action and other open items.
• Maintain knowledge base and internal information dissemination of existing and emerging regulations, standards, or guidance documents.
• Participate in internal audits, external supplier audits and QMS surveillance audits.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level