Quality Assurance Manager

Quality Assurance Manager for an Innovative BioTechnology Company

Kon'nichiwa!

We are looking for a Quality Assurance Manager in Madrid, to implement and oversee the company’s Quality Management System (QMS) and ensure compliance with international standards (ISO 9001, ISO 13485, etc.). This position will play a key role in managing audits, maintaining operational excellence, and ensuring adherence to regulatory requirements.

Responsibilities

• Develop and implement the company’s QMS, ensuring alignment with industry standards.
• Manage internal and external audits, including client and certification audits.
• Oversee quality documentation, including SOPs, manuals, and records.
• Train employees on quality systems to ensure consistent implementation.
• Address non-conformities and drive continuous improvement initiatives.

Requirements

• Bachelor’s degree in Biotechnology, Engineering, Life Sciences, or a related field. A Master’s degree in Quality Management is a plus
• 5+ years in quality roles within biotech, pharmaceuticals, or healthcare.
• Technical Knowledge: ISO standards (9001, 13485), FDA 21 CFR Part 820, and EU IVD regulations.
• Skills: Strong problem-solving, organizational, and communication skills. Advanced proficiency in English and Spanish.
• Preferred: Certification in Six Sigma or Lean Management; startup experience is a plus.

Benefits

• Salary Range: Open Salary according to seniority
• Lead quality management in an innovative and fast-growing company.
• A dynamic environment with impactful projects and career growth opportunities.
• Competitive benefits and workplace flexibility.

If you believe you're the ideal candidate for the Quality Assurance Manager role, do not hesitate to apply to the offer with your LinkedIn Profile or Uploading your CV. 

We will contact you very soon!

Truthfully, your People Partner