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Quality Management System Manager

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3Shape

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Location:
Poland , Szczecin

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

We are currently looking for a Quality Management System Manager who will join our team in Szczecin. This key role is vital in ensuring that everything we do meets our company standards and exceeds customer expectations. The position blends technical expertise with strategic leadership and leading a team of QMS Specialists. As the manager, you will provide mentorship, set performance goals, and foster a collaborative environment to enhance the global management system. Responsibilities span key areas such as Quality Compliance, Auditing, Corrective Action, QMS Certification, and Process Risk Management.

Job Responsibility:

  • Ensuring that processes needed for the Global Quality Management System are established, implemented, and maintained at all 3Shape sites
  • Ensure effective implementation and maintenance into the QMS of all requirements, documentation and records relevant to 3Shape scope of operation
  • Establish and maintain a framework for close cooperation between the Global QMS team and the process owners and/or other key stakeholders
  • Ensure effective knowledge sharing to help the process owners and/or other key stakeholders understand and interpret relevant requirements to implement them into their processes
  • Lead, manage and support CAPA & NCR process at all 3Shape locations
  • Establish an effective process for collecting data on QMS effectiveness and needs for improvement and ensure proper communication to the top management
  • Ensure an effective process for handling external audits and/or inspections and the actions resulting from them, in all locations
  • Actions to promote importance of the Global QMS
  • Support compliance and quality assurance processes

Requirements:

  • Bachelor's or Master's degree in a relevant field, such as quality management
  • 5 years of experience in certified management systems in a highly regulated environment
  • Experience in designing, implementing and improving of Quality Systems
  • Excellent understanding of quality requirements and regulatory principles within medical device industry (alternatively: automotive, aerospace or pharmaceutical industry)
  • Strong problem solving skills, focused on effective root cause and corrective actions
  • Manager responsible for leading a hybrid team, with ability to work independently and partner with cross‑functional stakeholders
  • Great interpersonal skills
  • Fluent Polish & English
  • Experience in working within cross-functional and multi-cultural teams

Nice to have:

  • Experience with GMP
  • Auditor competence and knowledge of ISO 13485
What we offer:
  • Attractive office with relax zones located in Szczecin, Poland
  • A vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues
  • An attractive Luxmed healthcare package with additional dentistry care
  • Fresh fruits, delicious and healthy lunches cooked by our canteen
  • We provide a great social work environment with many optional activities
  • Good work/life balance
  • Language courses with qualified teachers

Additional Information:

Job Posted:
May 10, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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