Design Quality Assurance Manager

2 days ago

Stockholm, Stockholm, Sweden Tobii Dynavox AB Full time

Join to apply for the Design Quality Assurance 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 a Design Quality Assurance Manager, you will join our global Quality Assurance and Regulatory team, where you will lead the quality assurance processes for both in-house and ODM-developed hardware. You will play a key role to ensure regulatory compliance and alignment with sustainability goals (e.g., material selection, recyclability) in hardware development. You will have a chance to collaborate cross-functionally to identify potential quality and safety risks associated with product design and reducing the likelihood of failures in the field.

If you are a detail-oriented, structured and analytical professional who thrives in a dynamic, global and regulated environment, this is a great opportunity for you

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

In this role, you will:

  • Lead OEM/ODMs quality assurance processes for hardware development to align with Tobii Dynavox and regulatory requirements.
  • Collaborate to conduct risk assessments (e.g., FMEA, Hazard Analysis), validation testing, and design reviews and to integrate risk mitigation strategies (e.g., design controls, validation testing) during early design phases into hardware development lifecycle.
  • Maintain an active and up-to-date Risk Management File for all hardware products throughout the product lifecycle, including post-market surveillance.
  • Verify that products transfer in result of robust, reliable, cost-effective, and appropriate manufacturing, packaging, and testing controls and transferred products comply with regulatory and Company requirements.
  • Review Design History Files (DHF) and risk management documentation to ensure compliance with ISO 13485, FDA 21 CFR Part 820) and other standards during design and development phases.
  • Monitor post-launch data for emerging risks and share insights with R&D team to improve future designs and prevent known risks from reoccurring.

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.
  • Equivalent of 5–8 years of experience in quality assurance or design control, with a focus on hardware development in industries such as medical device, healthcare, automotive.
  • Previous experience in conducting design reviews, validation and compliance with ISO 13485 and FDA 21 CFR Part 820. Experience on other global standards in product design and development phases is preferred.
  • Deep understanding of international standards and regulations for hardware products and product transfer processes.
  • Familiarity with sustainability practices in hardware development, including material selection and recyclability considerations.
  • Leadership and problem-solving skills to lead quality assurance processes, drive improvements across design and development lifecycle and address quality risks.
  • Communication skills in English (verbal and written) is required to collaborate with cross-functional teams, including R&D, manufacturing, and to manage external development partnerships.

Our Values:
At Tobii Dynavox, our mission guides what we do, and our values guide us in how we do it. Across the organization, we are committed to being Collaborative, Considerate, Curious and Courageous. We build a trusting environment where every team member prioritizes our customers with empathy and insight. Bold ideas and learning lead to impactful solutions. Driven by curiosity, we continuously challenge the status quo to create meaningful, customer-focused solutions for our customers.

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. Every day, your work makes a meaningful and concrete impact.
  • "Yes, and..." Flexibility: Build a rewarding career AND enjoy time with loved ones. We offer flexible work options so you don't have to choose between personal and professional goals.
  • Growth and Development: Whether you're advancing your skills or growing your career, 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. You'll feel connected to both your team and our global community.
  • 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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