Nox Medical

Nox Medical is a med-tech company that builds solutions for healthcare providers to diagnose sleep disorders. We offer devices, software, cloud and AI solutions that are at the forefront of the sleep medicine industry. We are a part of Nox Health, which is a global sleep health leader on a mission to improve the health of populations through better sleep. Every year, more than three million people in 50 countries benefit from Nox products and services. Nox provides a range of solutions from comprehensive sleep diagnostic technology for providers to value-based comprehensive sleep management programs for self-insured employers and payers.

Vinnustaðurinn

Senior Quality Specialist

We are seeking a highly skilled Sr. Quality Specialist to join our team. In this role, you will be responsible for ensuring compliance with national and internal quality system requirements, reviewing quality outputs, and supporting quality assurance initiatives across various functions.

As a medical device manufacturer, we run an ISO 13485:2016/MDSAP-certified Quality Management system.

Key Responsibilities

Review quality outputs for compliance with regulatory and internal quality system standards for medical devices
Assess document changes, change controls, validation, and qualification documents to ensure accuracy and appropriateness.
Manage CAPA and NCR systems by reviewing root causes, corrections, corrective actions, preventive actions, and effectiveness.
Conduct internal audits to ensure adherence to quality standards.
Collaborate in cross-functional projects, offering quality assurance expertise.
Provide quality-related consultancy on product development, subcontractor compliance, and third-party product compliance.
Assist during audits conducted by Notified Bodies, Conformity Assessment Bodies, and Regulatory Authorities, and contribute to corrective action planning.
Participate in training programs to enhance employee knowledge of quality standards.
Contribute to Quality Management System improvement projects.

Requirements

Bachelor’s or Master’s degree in a relevant field or equivalent experience.
Minimum 3 years of experience in medical device or pharmaceutical industry quality assurance.
Proven ability to conduct internal audits.
Strong documentation and organizational skills.
Demonstrated problem-solving capabilities and decision-making.
Ability to work independently with minimal supervision.
Fluent in English, with excellent verbal and written communication.