Вакансія Quality Expert (Szczecin, Poland)

Quality Management System led by Global QMS team located in Szczecin, is an integral part of 3Shape Group functionality and is valid in all locations, all over the world. As a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, our goal is to continuously improve the effectiveness and efficiency within the company.

QMS helps to coordinate organization activities to meet both customer and regulatory requirements and improve its effectiveness and efficiency on daily basis and based on ISO 13485:2016, FDA 21 CFR 820 and other requirements.

Your Profile

• Quality mindset with business approach
• At least five years of experience in QMS in an international organization
  (medical device industry)
• 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
• Experience 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 with minimum supervision

Your Responsibility:

• Develop Global QMS covering Poland, Denmark, US 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 4 locations
• Cooperate with all departments across the organization in implementing
  new/updated regulations
• Active participation in projects related to the Quality Management System
• Close cooperation with Danish Headquarter (travel to Denmark approx. 20-30 days per year)

We offer:

• Lots of interesting challenges that will develop you professionally
• Personal growth and development
• Work in professional, friendly and supportive environment
• Private healthcare and Multisport card to keep you fit and well
• English or German classes
• Seasonal parties to keep you connected with colleagues

We will be glad to welcome you in our team!

Please note that only resumes in English will be considered.