Quality Systems Manager

About the role

The Quality Systems Manager leads the strategy, deployment, and maintenance of Nextern's Quality Management System (QMS) across its US sites. This senior position ensures continuous compliance with ISO 13485 and FDA GMP standards while driving quality initiatives that support medical‑device design, manufacturing, and distribution.

Key responsibilities

• Define and monitor quality performance metrics and lead core QMS processes.
• Facilitate Management Review and other periodic reviews for the US site.
• Collaborate with PLM administrators to implement automated quality controls.
• Directly manage the Quality Systems team (engineers, specialists, technicians).
• Maintain scalable processes for CAPA, NCMR, Change & Document Control, Complaints, Training, and Audits.
• Align US and global sites for consistent QMS implementation and compliance.
• Manage relationships with notified bodies and regulatory agencies.

Required profile

• Bachelor’s degree or higher in a business or STEM discipline.
• 7+ years of experience with ISO 13485 and FDA GMP in Class II/III medical devices.
• Proven track record in gap analysis, QMS software selection/implementation, and multi‑site alignment.
• Experience writing, changing, and auditing QMS procedures.
• Strong background in managing Management Review and CAPA processes.

Required skills

• ISO 13485 compliance
• FDA GMP compliance
• Electronic QMS software implementation
• Gap analysis
• CAPA management
• Change and document control
• NCMR handling