Position: Senior Quality Management System Specialist (Poland, Szczecin)
Company: 3Shape
Category: Other
Experience required: 5y
English level: upper
Published: 2021-03-01T00:00:00+02:00

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,600+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world.

We are now looking for Senior Quality Management System Specialist to provide the best assist to our business partners.

Your Profile:
- Quality mindset with business approach
- At least five years of experience in QMS in medical device organization
- Experience with FDA Inspections, NB audits Solid knowledge of MDD/MDR, ISO 13485, FDA 21 CFR 820, MDSAP (knowledge of IEC 62304 is an advantage)
- Experienced Lead Auditor Experienced in managing cross functional and cross site projects related to QMS
- Fluent English (Polish is an advantage)
- Ready to learn and to share your knowledge
- Organized, flexible, communicative
- Can work independently, with minimum supervision

Your Responsibility:
- Develop Global QMS covering Poland, Denmark, US, UA and China
- Prepare gap analysis for processes and procedures vs. applicable regulations
- Conduct Internal Audits Conduct QMS trainings
- Help other departments to understand and interpret regulations
- Support Management and colleagues during external audits and inspections in all locations
- Cooperate with all departments across the organization in implementing new/updated regulations
- Active participation in the projects related to the Quality Management System
- Close cooperation with Danish Headquarter

We offer:
- Relocation allowance
- Work in an inspiring environment with social, knowledgeable and experienced colleagues
- A job with good work-life balance
- Part of global leading fast-growing company
- Lunch for 2 pln in our canteen
- Personal growth and development
- Friendly and supportive colleagues that are fun to spend time with
- Private healthcare with dental treatment and cafeteria benefit system to keep you fit and well

We will be glad to welcome you in our team!
Please note that only resumes in English will be considered.