3 дня назад
QA Operations Specialist (MedTech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QA Operations Specialist (MedTech): Supporting supplier quality management and operational quality assurance for point-of-care diagnostic solutions with an accent on supplier audits, deviations, CAPAs, and regulatory compliance. Focus on maintaining quality management systems, participating in audits and inspections, managing change and risk processes, and supporting QA release activities.
Location: On-site at HemoCue HQ in Ängelholm, Sweden
Company
HemoCue, a operating company, develops point-of-care diagnostic solutions for hemoglobin, glucose, HbA1c, and white blood cell testing.
What you will do
- Support supplier qualification, evaluation, monitoring, and audit activities.
- Manage supplier-related deviations, complaints, and CAPAs.
- Support day-to-day quality assurance activities across the organization.
- Maintain and improve the Quality Management System and review quality documentation.
- Participate in internal audits and regulatory inspections, including training and process compliance activities.
- Contribute to change control, risk management, and QA release activities.
Requirements
- University degree in life sciences, engineering, or a relevant equivalent field.
- Experience in quality assurance, preferably with supplier quality management.
- Basic understanding of GMP, ISO 13485, and ISO 27001 regulatory requirements.
- Strong analytical skills and a structured approach to work.
- Fluent English, written and spoken, is required.
Nice to have
- Experience working with a Quality Management System.
- Communication and collaboration skills, flexibility, self-direction, accountability, and a strong quality mindset.
Culture & Benefits
- Broad and developing responsibilities within the RAQA function.
- Opportunity to influence and improve quality processes.
- Collaborative and knowledge-driven work environment.
- Opportunities for professional development.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →