Overview
Software Quality Manager — Medical Devices role at Materialise. This position oversees the medical device quality management system across Materialise offices, coordinating software design and development activities, CAPA, QMR, KPIs, SOPs, internal audits, complaint monitoring, supplier management, and MAI.
Responsibilities
* Coordinate the medical device quality management system in synchronization with other Materialise offices, including software design and development, CAPA, QMR, KPIs, SOPs, internal audit, complaint monitoring, suppliers, and MAI
* Ensure 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 local certification audits
* Ensure implementation of the quality management system in 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
* Provide 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's 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
Qualifications
* A documented degree in an engineering, computing, science, medical, or mathematical discipline
* An experienced quality engineer with 5+ years of experience in managing a quality system, with particular experience in ISO 13485, EU MDR, MDSAP, including FDA regulations
* Ability to analyze medical device regulatory documentation 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 the 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)
* Good communication skills (demonstrated through interview or in-house performance)
* Great attention to detail and a quality-first mentality
* Able to attend business trips 4 times per year to the UK
Location and type of contract
* Barcelona, Spain
* Quality
* Full-time
* Hybrid
* Mid-senior level
* CV in English
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Software Development and Printing Services
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