QA/RA Specialist

Company Overview

Global Medical Device company specializing in dental equipment

Job Description

We are seeking a Quality Assurance Specialist to oversee and manage quality operations for our dental products, including equipment, materials, and implants. This role ensures compliance with regulatory requirements, maintains product quality standards, and fosters customer trust through proactive quality management.

Key Responsibilities

• Interpret the Pharmaceuticals and Medical Devices Act requirements and integrate them into our quality system documentation.
• Act as a subject matter expert on our quality systems and organizational processes.
• Maintain and review quality agreements with domestic and international manufacturers, ensuring QMS effectiveness.
• Monitor and analyze domestic market feedback on product quality, using insights to improve products and services.
• Investigate quality issues with global manufacturing sites, from root cause analysis to implementing preventive measures.
• Communicate quality-related findings to B2B and B2C customers, enhancing confidence in our products.
• Provide technical advice and quality information to customers and service engineers as needed.
• Collaborate across departments to embed a unified quality framework into all processes, ensuring safety and reliability.
• Plan, execute, and improve internal audits as a certified internal auditor, including reporting and verification of corrective actions.

Collaboration & Communication

• Regular interaction with global headquarters (Europe and Americas) across design, development, quality assurance, and marketing teams, as well as domestic sales, marketing, and service departments.

Requirements

Required:

• Experience in quality assurance/management for medical devices, or related roles such as regulatory affairs or safety management.
• Business-level English reading/writing and intermediate-level speaking skills (teleconferences with headquarters are in English).

Preferred:

• Knowledge of ISO 9001 (ISO 13485 preferred).
• Internal auditor certification for ISO 9001 (ISO 13485 preferred).