Document Control and Regulatory Compliance Coordinator

Harmonic Drive Group; Beverly (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

Harmonic Drive Group is seeking a dedicated individual for a full-time position focused on document control and regulatory compliance within their quality management system. Responsibilities include managing document workflows, compliance submissions, and assisting in audits. Candidates should have experience with AS9100 / ISO9001 standards and proficiency in Microsoft Office.

This role is pivotal in ensuring the quality and compliance of internal documentation, with a supportive work environment in Beverly, Massachusetts.

Qualifications

• Experience with AS9100 / ISO9001 document control quality management system.
• Ability to assist in various quality and customer audits.
• Sound computer skills and proficiency in Microsoft Office suite.

Responsibilities

• Responsible for managing and maintaining Documentation Control.
• Ensure regulatory compliance with accurate documentation.
• Assist in internal and external quality audits.

Skills

AS9100 / ISO9001 document control

Microsoft Office proficiency

Copy Exact / process control knowledge

Verbal and written communication

Knowledge of regulatory requirements (REACH, RoHS, etc.)

Education

Bachelor’s degree or equivalent experience

Job description

Summary/Objective

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.

Essential Document Control Functions

• 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.
• Prepare or maintain 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.

Essential Regulatory Compliance Functions

• 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

Requirements

Required Competencies

• 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.

Supervisory Responsibility

This position has no direct reports.

Work Environment

This job operates in a professional, open-concept, office and manufacturing environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, some of which may be done with accommodations. While performing the duties of this job, the employee is regularly required to communicate both verbally and in writing. The employee is frequently required to move about the office, use a computer, and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision.

Position Type/Expected Hours of Work

This is a full-time exempt position, Monday through Friday, during normal business hours.

Travel

No travel is required for this role

Required Education and Experience

• Bachelor’s degree required or equivalent experience.

Harmonic Drive LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

U.S. Export Controls Requirements: This job may require access to technology, materials, software or hardware that is controlled by the export laws of the United States. 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). This position is not eligible for immigration sponsorship.