Quality Manager

Hiring: Quality Manager

Are you passionate about quality systems and regulatory excellence in laboratory environments? We're looking for a Quality Manager to lead our clients compliance efforts and drive continuous improvement across our operations.

Your Impact

As our Quality Manager, you will:

• Lead ISO 15189 Quality Management: Maintain and update SOPs, oversee internal audits, and implement corrective actions.
• Champion Compliance: Ensure our lab meets CLIA certification requirements and IVDR standards for diagnostic testing.
• Educate & Empower: Keep the team informed on regulatory changes and foster a culture of quality awareness.
• Collaborate & Innovate: Work closely with lab leadership to develop new procedures and improve existing protocols.

Key Responsibilities

ISO 15189 Quality System

• Maintain and revise quality documentation and SOPs.
• Coordinate internal audits and follow up on corrective actions.
• Identify and implement process improvements.
• Ensure proper documentation and review of quality records.

Training & Awareness

• Stay current with regulatory updates.
• Train staff on QMS and quality control procedures.
• Promote user-centric quality practices across the lab.

CLIA Certification

• Develop a roadmap for CLIA compliance.
• Liaise with regulatory bodies to meet certification requirements.

IVDR Compliance

• Identify tests subject to IVDR.
• Register applicable tests and ensure ongoing compliance.
• Review new tests for IVDR alignment before implementation.

About You

• Proven experience with ISO 15189 quality systems.
• Background in molecular biology or similar lab environments.
• Experience working with Finnish authorities (e.g., FINAS, FIMEA) is a plus.
• Fluent in Finnish and English, both written and spoken.
• Detail-oriented, adaptable, and committed to regulatory excellence.