Document Control/Regulatory Compliance Coordinator - M

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.

Required Education and Experience

Bachelor’s degree required or equivalent experience.

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.
• 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 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