QS Specialist

Essential Responsibilities

This position will assist with the development, implementation, and monitoring of the Quality Management System (QMS) to include the Corrective and Preventive Action (CAPA) System, Design Control, Change Control and Records Control, Document Control, Training Records, Device History Records (DHR) and various other elements within the quality systems as it relates to regulatory compliance and Erbe Quality Systems. Additionally, this position will guide various other facets of the quality system, actively supporting system integrity, continuous improvement, and adherence to international medical device standards such as FDA 21 CFR 820 and ISO 13485.

• Provide support for the release and control of documents including updating current and archiving obsolete QMS documents. • Process document control changes and route new/updated documents for proper approvals. Documents include process instructions, forms and other documents for all areas of the business. • Provide training to individuals on related document control processes. • Ensures document changes are compliant with regulatory QMS and regulatory requirements. • Creates and revises job-specific training records, which list applicable Procedures, Work Instructions and Forms that are assigned to each specific job title. • Ensures current and previous revisions of Controlled Documents are properly maintained and controlled according to Erbe QMS requirements. • Participate in internal and external audits. • Support company goals and objectives, policies and procedures, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and FDA regulations • Revise documents and maintain revision control per FDA/ISO requirements. • Drive improvements and change to the Quality System Processes including implementation of Electronic Data Management Systems (EDMS) All other duties as assigned by the Quality Manager. • Establish and maintain training records. • Coordinate Change control process (CCP) and Quality Review requests (QRR). • Receive and coordinate incoming complaints from internal customers. • Assist with review of DHR and final acceptance and release. • Assist with Quality Control testing activities as required.

Supervisory Responsibility

This position is an individual contributor and has no direct supervisory responsibility.

Work Environment

This position operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.