Document Control and Regulatory Compliance Coordinator (US Citizenship Required)

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 FunctionsAssist 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 registrationMaintain employee training records, reports and requirements in the training databaseProvide 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.Essential Regulatory Compliance FunctionsEnsure 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 assignedRequired CompetenciesExperience 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 othersAbility to communicate effectively both verbally and written in English.Supervisory ResponsibilityThis position has no direct reports.Work EnvironmentThis job operates in a professional, open-concept, office and manufacturing environment.Physical DemandsThe 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 roleRequired Education and ExperienceBachelor’s degree required or equivalent experience.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.