QMS Specialist

Our client is an international company and one of the largest employers in the region. One of the main activities of the company is the design and manufacture of highly specialized equipment and diagnostic tools. Our client is a world leader in this industry.

NPI is a rapidly growing department responsible for new products introduction.  NPI is located very close to mass production and it’s supporting departments as they are key recipients. There is a strong project based collaboration with wide range of areas like Production, Logistics, Planning, Continues Improvement, Quality, Systems Engineering, Technical Department.

Working with our Client gives you the opportunity not only to plan your own work and be largely self-managed, but also to become a part of an experienced team of specialists capable of working in a dynamic and challenging international organization.

Your main tasks will be to:
• guide and review across NPI organization (FDA 820, MDD/13485)
- project documentation according to QMS
- project milestones and approvals
- change management
• continuous improvements of QMS process , checklists & templates
• support audits/inspections
• training NPI teams and individuals in regards to processes and compliance
• interface to other organizations in the area of Process and Compliance

* To perform the tasks you should expect some travelling – first year up to 1 week per month, next years up to 3 days per month.

You may hold a scientific bachelor degree, but your educational background is not decisive. You’ve already been working with Quality Management Systems and Quality System Standards, medical devices quality or project management for at least 3 years. Production, quality or R&D background will be an asset. You’re skilled within QMS, FDA CFR 21 part 820 and ISO -13485.

In order to succeed in this position, you need to thrive working independently and without too many guiding principles. Moreover, people see you as friendly, outgoing and collaborative, i.e. not a “quality control police officer”. Lastly, you are flexible, highly structured, possess a great overview and adaptable to changing circumstances.

• Attractive salary and benefit package
• International and dynamic environment
• Continuous learning and development including best training programs
• Great work atmosphere