Quality Assurance Manager (Healthcare, Remote)

Job summary

The Quality Assurance Manager is responsible for ensuring compliance with quality management systems and maintaining their relevance. This role involves conducting audits, providing training, and managing deviations to uphold quality standards.

Qualifications

• Educated as a Lab Technician or holds a B.Sc. or M.Sc. in a relevant field.
• Knowledge of GCP and ISO 15189.
• Theoretical and/or practical experience with GCP, GCLP, ISO 15189, IVDR or similar.
• Holds a Lead Auditor certificate.
• Fluent in English with strong writing and communication skills.

Responsibilities

• Prepare and approve audit plans.
• Conduct internal and external audits, including supplier audits and authority inspections.
• Facilitate customer audits at Center of Excellence sites.
• Provide quality training and maintain the Quality Management System.
• Manage deviations, including root cause analysis and CAPA.
• Report Key Performance Indicators (KPIs) to Management and Group QA.
• Participate in meetings and support quality-related projects.
• Review Master Service Agreements and act as the QA representative in authority registers.
• Prepare the Quality Management review.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a regulated environment.

Education

• Lab Technician certification or a B.Sc./M.Sc. in a relevant field.

Tools

• Quality Management Systems, audit management tools, and relevant compliance software.