Global Quality Management System Director

1 day ago

Stockholm, Stockholm, Sweden Tobii Dynavox AB Full time

Tobii Dynavox AB is a leading provider of assistive communication technology. Our mission is to empower individuals with disabilities to express themselves, connect with the world, and pursue independence.

About the Role:

As our Global Quality Management System Manager, you will play a key role in ensuring the quality of our products and services. You will lead the design and implementation of a compliant, centralized, and simplified quality framework across the organization, and continuously improve it. Your role will be critical in harmonizing Process Quality review with Group Business Objectives by driving Quality projects and supporting projects in quality compliance matters.

You will be part of our global Quality Assurance and Regulatory team, responsible for Group Quality Certificates and Subject Matter Expert for Non-Product Software Validation (NPSS), Quality Management System (QMS), Document Control, Internal and External Audits, and Training.

  • Plan and execute Global Quality Audits (internal, supplier, partners) using a risk-based model, including audit frequency, duration, and number of auditors.
  • Lead corrective actions and risk mitigation plans in response to Certification Body audit findings or compliance issues.
  • Adopt digital Quality tools and Solutions to streamline quality documentation, workflows, and compliance in collaboration with the IT team.
  • Design and maintain dashboards for real-time quality performance monitoring. Identify potential quality risks and provide actionable recommendations to mitigate issues prior to strategic decisions.
  • Coordinate development of Group Quality Objectives and their integration in the Operational Planning. Monitor and report on Key Process performance metrics to senior leadership, identifying areas for process optimization.
  • Collaborate with Quality Operations and Performance Manager for consistent quality practices and support our Business Excellence team in implementing governance policies across the Group.
  • Conduct thorough quality assessments as part of the due diligence process for mergers, acquisitions, or partnerships.
  • Draft and update Intra-company quality agreements.
  • Lead global training programs, competency assessments, and initiatives to foster a proactive quality culture.

Please note that this is a full-time on-site role at our office in Stockholm city with flexibility to work remotely one-two days when needed.

We are looking for someone with:

  • Bachelor's or Master's degree in Engineering, Quality Management, Life Sciences, or a related field.
  • 7 years of experience with quality management systems, preferably for Group Certification and in a global organization in regulated industries (i.e. medical device and pharmaceutical).
  • Advanced knowledge and experience in compliance with ISO 13485, FDA QSR, and MDR. Experience with other relevant international regulations on product quality and safety standards are preferred.
  • Previous experience in planning and leading audits (internal, supplier, and external), including risk-based audit models is required. Previous experience on quality assessments as part of due diligence for mergers, acquisitions, or partnerships is highly appreciated.
  • Ability to design effective and lean QMS structures with an understanding of quality documentation, and compliance workflows.
  • Expertise in quality risk management, CAPA processes, and process quality review methodologies and familiarity with non-product software validation (NPSS).
  • Strong problem-solving and analytical skills to identify potential quality risks, providing actionable recommendations and report on key process performance metrics to senior leadership.
  • Cross-functional collaboration and leadership skills to align global objectives with business operations and foster a proactive quality culture.

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