Quality Manager
Materialise
What you will do
- You are responsible for the global medical quality system, enabling global compliance with corporate and local quality procedures and regulatory requirements. The scope is the global medical quality management system compliance, and the interactions with entities are not fully integrated (i.e., Materialise Southampton).
- When appointed, you will be the management representative. This entails 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, and promoting awareness of applicable regulatory and quality management system requirements throughout the organization, including Materialise Japan, Materialise Colombia, Materialise Southampton, Materialise 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 across the world. To this end, you are a functional manager for the regulatory affairs project manager and senior regulatory affairs officer. You monitor, among others, company registrations, product registrations, vigilance activities, and regulatory notification/reporting.
- Monitor, via team members who are 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, and social media.
- Ensure implementation of a quality management system within corporate global and local management teams, e.g., purchasing system/supplier evaluations, document control, and electronic documents/records. Liaise with the medical business unit's director of the operations team to ensure streamlined application of QMS principles throughout quality management, production, and process engineering.
- Champion FDA compliance at all Materialise locations, ensuring successful inspections, which you will attend and steer.
- Follow up on non-medical software development activities to ensure uniformity with medical software development. Liaise with our additive manufacturing software quality team.
- Mentor the quality engineer for MatUSA, the point of contact with the FDA, and coordinate with the MatUSA managing director where needed in this respect.
- Attend business trips 4 times per year to the UK and Spain
- Degree educated in a business-, computing-, science-, medical-, or mathematical-based discipline. These qualifications are documented within individual personnel records.
- Applicant should be an experienced quality manager with 5+ years of experience managing a quality system, with experience in 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 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 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).
- 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).
- Kyiv, Ukraine
- Quality
- Full-time
- Hybrid
- Mid-senior level
- CV in English
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