QA Specialist

• Multiple locations
• Hybrid

We are looking for a for a sharp dedicated and highly ethical QA Specialist who specialized in Quality Systems & Data to spearhead the digital evolution of our Quality Department. As the QA Specialist you will be responsible for the strategic implementation of Electronic Quality Management System (e-QMS) and will serve as the primary data controller by ensuring our data integrity. This role is pivotal in ensuring that our quality documentation and data management processes meet the highest standards of accuracy traceability and regulatory compliance.

Organizational context & reporting

This position reports directly to the Senior Quality Assurance Manager working in close synergy with the Quality Assurance and Quality Control teams.

In this role you will also act as a bridge between quality and other business units to ensure that digital data workflows are standardized and consistently followed across the organization.

Key Responsibilities

Your responsibilities will include but not be limited to:

• e-QMS Implementation & administration: Lead the end-to-end transition from manual/legacy systems to a digital e-QMS ensuring system configuration aligns with organizational workflows.
• Data Controller & Governance: Act as the primary custodian for quality-related documentation. Ensure all data is accurate traceable and compliant with relevant industry standards (e.g. ISO 13485).
• Process optimization: Analyse existing quality workflows to identify opportunities for digitalization and increased operational efficiency.
• Technical documentation & training: develop comprehensive SOPs (Standard Operating Procedures) for digital tools and conduct corporate training sessions to ensure organizational alignment.
• Audit Readiness: Maintain an audit-ready digital environment facilitating both internal and external inspections through meticulous data organization.