Quality Manager — Medical Devices (вакансія неактивна)

Are you passionate about healthcare and technology? Join Materialise as a Quality Manager. In this role, you will develop, document, and monitor medical device QMS documentation that conforms to the requirements of the regulatory bodies to which we are associated. Maintain QMS compliant with the EU MDR, MDSAP, and ISO 13485.

Key Responsibilities:

• Coordination of the medical device quality management system in synchronization with other MTLS offices: Software Design and Development, CAPA, QMR, KPIs, SOPs, Internal audit,
  Complaint monitoring, Suppliers and MAI. Ensures continued compliance with medical device agency regulations and standards, including certification activities.
  
  
• Support Materialise’s global footprint by ensuring the product complies with Q&R requirements. Support regulatory technical documentation and registrations, including supporting local certification audits.
  
  
• Ensure implementation of the quality management system with compliance with regulatory requirements (EU MDR/MDSAP), standards (ISO 13485) and customer needs. Assist in supporting the quality management system and quality policy to achieve and maintain the highest level of quality while enhancing value for our customers, driving innovation, growing infrastructure and knowledge and increasing service and product functionality and quality.
  
  
• Provide Quality support for the medical unit, assisting with writing, reviewing and approving standard operating procedures to ensure regulatory compliance. Review design development documentation, change requests, service requests, risk management activities, product complaints, corrective action requests, process/product validations, and investigate/resolve quality-related issues.
  
  
• Provides statistical trend analysis on the quality management system. Monitor processes to identify potential deficiencies, communicate these issues and initiate additional actions. Manage and monitor to ensure deficiencies are resolved and corrective/preventive actions are implemented and effective.
  
  
• Liaise with the company regulatory experts to ensure that we comply with any necessary standards.
  
  Identify process improvements or breaches, document and track them through to resolution.
  
  Organize and minute the necessary medical management meetings
  
  

Required Skills & Qualifications:

• Degree educated in Engineering, Computing, Science, Medical or Mathematical Based Discipline. These qualifications are documented within individual personnel records.
  
  
  

Experience

• Applicant should be an experienced quality engineer with 5+ years of experience in managing a quality system, with particular experience ISO 13485, EU MDR, MDSAP including FDA regulations. Pre-joining experience is documented within individual personnel records.
  
  
• Ability to analyse medical device regulatory documentation and to derive the necessary changes needed to conform (demonstrated in interview or from in house performance).
• Demonstrated understanding of the importance of quality — including good documentation practices, understanding of the importance of process and documentation (demonstrated in house or through interview and relevant experience).
• Experienced in delivery of quality systems in a software environment (demonstrated through previous held positions and projects).
  
  
• Knowledge of key medical software regulation practices and procedures and the auditing processes associated with them (demonstrated in interview or from in house performance).
  
  
• Possession of good communication skills (demonstrated through interview or in house performance).
  
  
• Great attention to detail and quality first mentality (demonstrated in interview or from in house performance).
  
  
• Attend business trips 4 times per year to the UK and Spain