Software Quality Manager — Medical Devices
Materialise
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.
- 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
- Kyiv, Ukraine
- Full-time
- Hybrid
- Mid-senior level
- CV in English
Як відгукнутися?
Щоб відгукнутися на цю вакансію, вам необхідно авторизуватися на нашому сайті. Якщо у вас ще немає облікового запису, будь ласка, зареєструйтесь.
Розмістити резюмеСхожі вакансії
Барбер
Aled,
Київ,
3 години тому
Вакансія: Барбер у новий барбершоп (Київ, Солом’янський район) У Солом’янському районі Києва відкривається новий барбершоп, і ми шукаємо барберів, які хочуть стати частиною команди з самого старту! Ми відкриті до кандидатів без досвіду — у нас є власна школа , де ми навчимо всьому необхідному! Що ми пропонуємо: Гнучкий графік роботи — обговорюється індивідуально Оплата відсотком: — % від кожної...
Слюсар-сантехнік
Atmosfera,
Київ,
22 000 ₴
7 годин тому
Обов’язки: досвід роботи на аналогічній посаді (виконання ремонтних робіт трубопроводів ХВП, ГВП, ЦО та каналізації в житлових будинках (та квартирах) не менше 3-х років); бажано технічна освіта; знання принципу роботи ІТП (індивідуальний тепловий пункт), насосної станції; обслуговування внутрішньо інженерних мереж: ХВП, ГВП та каналізації; розбиратись в схемах та вміти їх читати; усунення аварійних ситуацій на інженерних мережах; відповідальність і порядність,...
Digital Performance Analyst
Visa,
Київ,
9 годин тому
Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year. Our mission is to connect the world through the most innovative, convenient, reliable, and secure payments network, enabling individuals, businesses, and economies to thrive while driven...
