QS Specialist

Erbe USAorporated•Tempe, AZ

11d•Onsite

About The Position

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.

Requirements

High School Diploma
2-5 years of experience in Quality Systems
Medical device industry (particularly ISO 13485) or a regulated industry experience preferred
Quality Management Systems (QMS) experience required
Excellent verbal and written communications required
Strong facilitation and interpersonal skills required
Must be able to communicate complex information to all levels within the organization
Demonstrated high quality computer skills including MS Office
Must be detail-oriented and produce high quality work in a high-volume environment
Must be able to handle confidential information in an appropriate and professional manner
Ability to remain flexible and open to change within a fluid global industry
Employees must be legally authorized to work in the United States
Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government

Nice To Haves

Bilingual (Spanish) is highly preferred

Responsibilities

Assist with the development, implementation, and monitoring of the Quality Management System (QMS)
Manage Corrective and Preventive Action (CAPA) System, Design Control, Change Control and Records Control, Document Control, Training Records, Device History Records (DHR)
Ensure regulatory compliance and adherence to Erbe Quality Systems
Support 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
Provide training to individuals on related document control processes
Ensure document changes are compliant with regulatory QMS and regulatory requirements
Create and revise job-specific training records
Ensure current and previous revisions of Controlled Documents are properly maintained and controlled
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)
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