Senior Quality Assurance Manager

Skills Alliance; Baden-Württemberg; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading medical device consulting firm is seeking a Senior Quality Manager to lead quality assurance activities. The role requires ensuring compliance with global standards and managing a quality management system. Ideal candidates will have over 5 years of experience in the medical device industry and strong knowledge of relevant regulations. This full-time position is located in Baden-Württemberg, Germany.

Qualifikationen

• 5+ years of experience in quality assurance within the medical device industry.
• Proven experience leading quality teams and managing quality systems in regulated environments.

Aufgaben

• Lead and manage the implementation and maintenance of the Quality Management System (QMS).
• Oversee internal and external quality audits, including supplier and notified body audits.
• Drive continuous improvement initiatives related to quality processes.
• Monitor and report on key quality metrics to senior management.

Kenntnisse

ISO 13485

FDA QSR

Risk management

Leadership

Ausbildung

Degree in Life Sciences or Engineering

Jobbeschreibung

Senior Quality Manager – Medical Devices

About the Role

Skills Alliance is proud to partner with leading organisations in the medical device sector. We are currently seeking a Senior Quality Manager with 5+ years of experience to lead and support quality assurance activities, ensuring compliance with global quality standards and regulatory requirements.

Responsibilities

• Lead and manage the implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant standards.
• Oversee internal and external quality audits, including supplier and notified body audits.
• Drive continuous improvement initiatives related to quality processes and compliance.
• Manage CAPA, non-conformances, risk management, and change control activities.
• Collaborate closely with R&D, Manufacturing, and Regulatory teams to ensure quality standards are met throughout product lifecycle.
• Provide leadership and training to quality teams and cross-functional departments on quality systems and compliance.
• Monitor and report on key quality metrics to senior management.

Requirements

• Degree in Life Sciences, Engineering, or related field.
• 5+ years of experience in quality assurance within the medical device industry.
• Strong knowledge of ISO 13485, FDA QSR, MDR, and risk management (ISO 14971).
• Proven experience leading quality teams and managing quality systems in regulated environments.

If you’d like to explore exciting opportunities in medical devices, apply now or connect with me directly for a confidential conversation.

Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing