Medical Devices Quality Assurance Specialist

Join our team and make a difference in the lives of patients by ensuring the quality of our medical devices.

Position: Medical Devices Quality Assurance Specialist

Location: Kecskemét, Hungary

Industry: Medical Devices

Employment Type: Contract

About the Role: We are seeking a highly skilled and detail-oriented Medical Devices Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the safety, effectiveness, and quality of our medical devices. You will be responsible for overseeing all aspects of the quality management system, including compliance with regulatory requirements and standards.

Key Responsibilities:

• Develop and maintain quality assurance policies and procedures in compliance with relevant regulations and standards such as FDA, ISO, and other international requirements.
• Provide guidance and support to cross-functional teams on quality-related matters, ensuring adherence to quality standards and regulatory requirements.
• Conduct risk assessments and implement risk management strategies to ensure the safety and effectiveness of our medical devices.
• Lead and participate in internal and external quality audits, ensuring timely closure of any identified non-conformities.
• Develop and maintain quality metrics to monitor the effectiveness of the quality management system and identify areas for improvement.
• Review and approve all quality-related documentation, including quality plans, test protocols, and reports.
• Investigate product quality issues, identify root causes, and implement corrective and preventive actions.
• Collaborate with suppliers to ensure the quality of incoming materials and components used in the production of medical devices.
• Stay current on industry trends and regulatory changes, and implement necessary updates to the quality management system.
• Train and mentor team members on quality best practices and procedures.

Qualifications:

• Bachelor's degree in a scientific or engineering field.
• Minimum of 3 years of experience in quality assurance in the medical device industry.
• Strong understanding of FDA regulations, ISO standards, and other relevant quality requirements.
• Experience with risk management and root cause analysis.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Strong analytical and problem-solving skills.
• Detail-oriented with a high level of accuracy and precision.
• Proven ability to work independently and manage multiple projects simultaneously.
• Quality auditor certification is a plus.

Apply now and be a part of our mission to improve healthcare through innovative and high-quality medical devices.