Software Quality Manager — Medical Devices
Are you passionate about healthcare and technology? Join Materialise as a Quality Manager. In this role, you'll develop, document, and monitor medical device QMS documentation that conforms to the requirements of our associated regulatory bodies and maintain a QMS compliant with the EU MDR, MDSAP, and ISO 13485.
What you will do
- 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 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.
Your profile
- 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 and Spain
What we offer
Healthy life-work balance
When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony.
Hybrid working & flexibility
At Materialise, we value the power of in-person connections and the advantages of remote work, allowing our employees the flexibility to enjoy the best of both worlds. You can work remotely up to 60% of the time and work flexible hours, depending on your particular role.
Personal growth and career advancement
At Materialise, we’re committed to nurturing the professional development of our employees. We invest in our passionate people and empower them to explore and grow by offering diverse career paths that capitalize on their talents. Plus, we offer courses, external coaching programs, and in-house mentoring so that our employees can fulfill their potential.
Team building
We cultivate a positive work culture so our employees have an enjoyable professional environment. Collaboration is key, so we organize activities that unite our employees, such as after-work events and team lunches. We want all our staff to feel connected in an environment that promotes strong bonds based on trust, respect, empathy, and friendship.
Innovation is key
Innovation is not just a buzzword at Materialise; it's at the core of what we do. As pioneers in our industry, we create cutting-edge solutions, fostering an environment that supports and rewards ingenuity and leadership. We’re dedicated to shaping the future of 3D printing, recognizing and celebrating the creative spirit within all our global innovators.
Healthy life-work balance
When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony.
Hybrid working & flexibility
At Materialise, we value the power of in-person connections and the advantages of remote work, allowing our employees the flexibility to enjoy the best of both worlds. You can work remotely up to 60% of the time and work flexible hours, depending on your particular role.
Personal growth and career advancement
At Materialise, we’re committed to nurturing the professional development of our employees. We invest in our passionate people and empower them to explore and grow by offering diverse career paths that capitalize on their talents. Plus, we offer courses, external coaching programs, and in-house mentoring so that our employees can fulfill their potential.
Team building
We cultivate a positive work culture so our employees have an enjoyable professional environment. Collaboration is key, so we organize activities that unite our employees, such as after-work events and team lunches. We want all our staff to feel connected in an environment that promotes strong bonds based on trust, respect, empathy, and friendship.
Innovation is key
Innovation is not just a buzzword at Materialise; it's at the core of what we do. As pioneers in our industry, we create cutting-edge solutions, fostering an environment that supports and rewards ingenuity and leadership. We’re dedicated to shaping the future of 3D printing, recognizing and celebrating the creative spirit within all our global innovators.
Location and type of contract
- Belgium, Leuven
- Full-time
- Hybrid
- Mid-senior level
- CV in English
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Working at Materialise
Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.
As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.