Quality Systems Leader – Medical Devices & ISO 13485

Nextern; Maple Grove (MN); Presencial; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Care Plan

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND 生日休假

Lifetime Membership Subsidy and Wel­l­

Life Insurance (Basic, Voluntary & AD&

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays!!!

Descripción de la vacante

NPX Medical, a division of Nextern, is seeking a Quality Systems Manager to lead the Quality Management System, align with regulatory agencies, and coordinate global initiatives. The role oversees CAPA, Change Control, Document Control, and audits to ensure product quality and regulatory conformity.

The ideal candidate has a STEM degree with 7+ years in ISO 13485 and FDA GMP, and 2+ years in quality management, plus strong communication skills.

Formación

• 7+ years of ISO 13485 and FDA GMP experience.
• 2+ years of Quality management experience.
• Excellent Written & Oral Communication Skills.

Responsabilidades

• Directly manage relationships with the ISO notified body.
• Lead Quality Systems Team and establish scalable, compliant processes (CAPA, Change Control, Document Control, Customer Feedback, Training).
• Oversee audits and regulatory readiness for internal and external assessments.
• Define and cascade department objectives and vision.
• Develop and implement company policies and procedures; provide timely staff evaluations.
• Supervise staff and manage hiring, training, and development.

Conocimientos

Quality management

ISO 13485

FDA GMP

Regulatory audits

Documentation

Communication skills

Educación

Bachelor’s degree in STEM

Descripción del empleo

NPX Medical, a division of Nextern, is seeking a Quality Systems Manager to lead the Quality Management System, align with regulatory agencies, and coordinate global initiatives. The role oversees CAPA, Change Control, Document Control, and audits to ensure product quality and regulatory conformity.

The ideal candidate has a STEM degree with 7+ years in ISO 13485 and FDA GMP, and 2+ years in quality management, plus strong communication skills.