Quality Manager — Medical Devices

Are you passionate about healthcare and technology? Join our company as a Quality Manager.


Key Responsibilities :

• You are responsible for the global medical quality system, allowing global compliance to corporate and local quality procedures and to regulatory requirements. The scope is the global medical quality management system compliance, and the interactions with entities not fully integrated (ie Materialize Southampton).
• Management representative, when appointed, responsible for ensuring that processes needed for the quality management system are documented, reporting to top management on the effectiveness of the quality management system and any need for improvement, ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization, Materialize Japan, Materialize Colombia, Materialize Southampton, Materialize USA.
• You ensure that Corporate Medical and business/service unit Management Reviews are held in accordance with applicable standards and procedures, and that relevant data is gathered.
• You monitor the status of medical regulatory projects to ensure regulatory compliance for distribution activities around the world.  To this end, you are a functional manager to the regulatory affairs project manager and senior regulatory affairs officer. You monitor, among others, company registrations, product registrations, vigilance activities, regulatory notification/reporting.
• Monitor, via team members more directly involved, the status of medical labeling (claims) projects to ensure regulatory compliance with technical files across the world with regulatory officers, including labels, instructions for use, marketing pieces, social media
• Ensure implementation of quality management system within corporate global and local management teams, as an example, Purchasing system/Supplier Evaluations, Document Control, Electronic Documents/Records. Liaise with the Medical Business Unit's Director of Operations team to ensure streamlined application of the QMS principles throughout Quality Management, Production and Process Engineering.
• Champion FDA compliance  at all Materialize locations, ensuring successful inspections, which you will attend and steer.
• Follow-up of non-medical software development activities but only to ensure uniformity with medical software development. Liaise with SAM quality.
• Mentor Quality Engineer MatUSA, Point of Contact for MatUSA with FDA; coordinate with the MatUSA Managing Director where needed in this respect.
• Business trips 4 times per year to the UK and Spain
  
  

Required Skills & Qualifications :

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

Experience

• Applicant should be an experienced quality manager with 5+ years of experience in managing a quality system, with particular experience of Medical Device Regulations (US, EU, Canada, Japan, Australia, Brazil, etc.). Pre-joining experience is documented within individual personnel records.
• Ability to analyze 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 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 previously 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).