Global Quality Management System Manager

3 days ago

Stockholm, Stockholm, Sweden Tobii Dynavox AB Full time
Global Quality Management System Manager

Join to apply for the Global Quality Management System Manager role at Tobii Dynavox

Why Join Us?
At Tobii Dynavox, we empower people with disabilities to do what they once did or never thought possible. We call this mission Power to Be You. Our assistive communication technology helps our customers express themselves, connect with the world, and pursue independence, whether through everyday activities like ordering food or extraordinary feats like running a company. Working at Tobii Dynavox, you'll become part of a team that spans the globe, with offices in the US, Sweden, France, the UK, China, and beyond.

About the Role:
As our Global Quality Management System Manager, you will support the daily activities of Tobii Dynavox and partners in delivering high-quality products by leading the design and implementation of a compliant, centralized, and simplified quality framework across the group and continuously improving it. Your role will be key 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.

In this role, you will:

  • 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: Our core working hours are 8:30 am-5:30 pm from Monday to Friday. This is a full-time on-site role at our office in Stockholm city with flexibility to work remotely one-two days when needed.

What We're Looking For:
We are looking for someone that has:

  • 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.

Please note: If you have any trainings or certifications such as:

  • Certified ISO 13485 Auditor, Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or similar certifications (e.g., ASQ, IRCA) please mention or attach them in your application.

Our Values:
At Tobii Dynavox, our mission guides what we do, and our values guide us in how we do it. We are committed to being Collaborative, Considerate, Curious, and Courageous.

What We Offer:
At Tobii Dynavox, we believe in empowering individuals – including our employees - to reach their full potential. Here's what makes us unique:

  • Purpose-Driven Work: Join a company that transforms lives by giving a voice to those with communication challenges.
  • "Yes, and..." Flexibility: Build a rewarding career AND enjoy time with loved ones.
  • Growth and Development: We invest in your future with training, learning opportunities, and internal growth paths.
  • Inclusive and Supportive Culture: Work in a collaborative, caring environment where diversity and individuality are valued.
  • A Global Leader with Heart: Be part of an innovative, forward-thinking company that combines experience and cutting-edge solutions with a mission to change lives.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

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