Вакансія Quality Audit Specialist (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 three years of experience in QMS, preferably in an international organization
• Previous experience in a highly regulated industry (e.g. medical device, pharma, automotive)
• Experience in FDA, GMP, ISO 13485 would be an advantage
• Experienced Internal Auditor
• Experienced in third party audits and inspections
• Fluent english (polish is an advantage)
• Ready to learn and to share your knowledge
• Organized, flexible, communicative
• Can work with minimum supervision

Your Responsibility:

• Developing Quality Audit process in Global QMS - Poland, Denmark, US and China
• Recruiting new Internal Quality Auditors and providing relevant trainings
  in all 4 locations
• Managing global Internal Quality Audit Plan
• Supporting Management and colleagues during external audits and inspections
  in all 4 locations
• Managing CAPAs related to internal and external audits and inspections
• Cooperation with all departments across the organization
• Active participation in the projects related to the Quality Management System
• Strong 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.