Quality Systems Manager

Quality Systems Manager

The Quality Systems Manager is responsible for strategy, deployment, alignment, and maintenance of the Quality Management System for Nextern US sites. The role is also responsible for the selection, implementation, administration, and monitoring of the Quality Management System ensuring continual compliance of the organization. The role owns the audit, certification, and relationship maintenance of the company's notified body and regulatory agency registration processes and coordinates functional leadership to properly resource and prioritize Quality initiatives.

Duties and Responsibilities:

• Lead quality initiatives related to core QMS processes and systems
• Define Quality performance metrics and implement systems to monitor performance
• Facilitate Management Review and other periodic reviews, as necessary, for Nextern US site
• Serve as liaison to PLM administrator to effectively implement automated controls aligned with Quality System requirements
• Directly manage Quality Systems team, including engineers, specialists, and technicians
• Establish and periodically review scalable and compliant Quality System processes including, but not limited to: CAPA, NCMR, Change and Document Control, Complaints, Training, and Audits
• Establish alignment and accountability between Nextern US (corporate) and global Nextern sites for effective implementation, maintenance, and sustained compliance of the quality system
• Directly manage the account relationships between Nextern and its notified bodies
• Performs other related duties as assigned by management.

Supervisory Responsibilities:

• Directly supervises employees within the Quality Systems departments.
• Dotted-line supervision/mentoring of Quality Systems analysts at Nextern's global facilities.
• Carries out supervisory duties in accordance with organizational policies and applicable laws.