Quality Systems Manager

NPX Medical is a division of Nextern — a global, vertically integrated medical device development and manufacturing platform. We specialize in precision metal components and assemblies, with deep expertise in nitinol engineered components, precision laser cutting and processing, and advanced catheter technologies. Our engineers bring decades of combined experience — from R&D and rapid prototyping through full commercial production.

At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

The Quality Systems Manager will be responsible for strategy deployment, alignment, and standardization of the Quality Management System and Quality Systems Team (engineers, technicians, and inspectors). You will own the audit, certification, and relationship maintenance of the company’s notified body and regulatory agency registration processes and coordinate global leadership teams to properly resource and prioritize initiatives relating to facility certification business strategies.

You will oversee the programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency regulations.

RESPONSIBILITIES:

• Directly manage the relationships between NPX Medical and their ISO notified body.
• Directly manage the Quality Systems Team in effectively establishing scalable and compliant systems and processes (i.e. CAPA, Change Control, Document Control, Customer Feedback, Training, etc) and supporting Customer, Internal & Regulatory Audits.
• Lead compliance initiatives for core QMS processes and standardization of quality metrics.
• Define and communicate overall vision and cascade objectives for the department.
• Develop, train, implement and continuously approve upon company and business unit policies and procedures.
• Provide timely performance & developmental evaluations of departmental staff.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Directly supervises employees within the Quality Systems Team.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Requirements

• Required: Bachelor’s degree in a STEM related field
• 7+ years of relevant experience in ISO 13485 and FDA GMP.
• 2+ years of Quality management experience
• Excellent Written & Oral Communication Skills.
• Experience with configuration of reports, security/access, data structuring, meta-data fields, and workflows.
• Medical device experience
• Preferred: Experience in implementing foundational and expandable quality system strategies in a small-mid size company.
• Project management experience in transitioning to the ISO 13485:2016 standard.
• Project management experience in implementing an eQMS systems.
• Training/certification in Lean and Six Sigma
• Training/certification in lead auditing ISO 13485 and FDA GMP systems
• Previous CDMO experience

Salary range: $120,000 to 160,000 depending on skills and experience