Are you passionate about quality and eager to contribute to safe and compliant medical products that make a global impact? Do you enjoy working in an international environment where collaboration, precision, and innovation come together? Then this is your opportunity! Read more about this position as Quality Systems Specialist.
Job Description
This international organization plays an important role in improving global healthcare by developing and distributing high-quality medical products.
As a Quality Systems Specialist, you are a key link within the Quality Management System (QMS). You will manage documentation, systems, and processes that ensure compliance with international standards such as ISO 13485, EU MDR, and FDA requirements.
In this role, you will collaborate closely with various internal departments, including logistics, production, customer service, and regulatory affairs and external partners such as legal manufacturers, distribution centers, and the Responsible Person for the medical product segment.
You will join a small, dedicated quality team where openness, teamwork, and a commitment to excellence are central. This position offers a high level of autonomy, variety, and the opportunity to make a meaningful contribution to the quality and compliance of products with global reach.
Responsibilities
- Manage and monitor documentation processes within the QMS, ensuring alignment with local and global regulations
- Act as system administrator for quality-related software tools and ensure efficient and compliant operation
- Analyze KPIs and support improvement initiatives related to document management and material blocking
- Support the Responsible Person and Quality Head with supplier qualifications, CAPAs, SOP updates, internal audits, and quality reviews
- Act as point of contact for deviations and CAPAs within commercial operations and perform root cause analyses
- Coordinate material blocking and return processes together with global complaint management teams
- Maintain communication with external partners such as warehouses and repair shops to support product-related activities (e.g., rework, scrap)
- Prepare reports for Site Quality Management Reviews and monthly KPI updates
- Archive quality documentation and ensure data quality and integrity
- Support training activities on quality topics such as GxP, Data Integrity, and relevant regulations
- Provide general quality support as needed within the team
Profile
- Minimum of a Bachelor's degree
- At least 2 years of experience in Quality or Project Administration
- Experience with Document Control, GxP, and handling of non-conforming products
- Strong skills in Microsoft Office and document management systems
- Excellent communication skills in English (both written and spoken)
- Organized, customer-focused, flexible, and result-oriented mindset
- Experience working in a multicultural and international environment
Employment Conditions
- Contract: Start with Oxford Global Resources
- Salary indication: €3,300 - €4,300 gross per month (depending on education and experience)
- Working hours: 32-40 hours per week
- Work model: Hybrid remote work possible for 1-2 days per week
- Language: English
- Vacancy number: 26642
Are you excited about this opportunity and want to know more or apply directly?
Contact us today! We'd be happy to tell you more about this unique role.
