Senior Quality Management System Specialist
Miejsce pracy: Szczecin
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.
Our offer:
- 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 wel
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
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