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.

Requirements

• 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 it’s notified bodies
• Performs other related duties as assigned by management.

Benefits

• Employer subsidized health insurance and dental insurance for employees
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance