Design Quality Assurance Manager
Design Quality Assurance Manager
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Job Description
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 youll become part of a team that spans the globe with offices in the US Sweden France the UK China and beyond.
To learn more about what we make possible meet some of our customers or take a look at some of our solutions.
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 inhouse and ODMdeveloped 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 crossfunctionally to identify potential quality and safety risks associated with product design and reducing the likelihood of failures in the field.
If you are a detailoriented 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 am5:30 pm from Monday to Friday. We have flexibility working hours to collaborate better and globally. This is a fulltime onsite role at our office in Stockholm city with flexibility to work remotely onetwo 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 uptodate Risk Management File for all hardware products throughout the product lifecycle including postmarket 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 postlaunch data for emerging risks and share insights with R&D team to improve future designs and prevent known risks from reoccurring.
What Were Looking For:
We are looking for someone that has:
Bachelors or Masters degree in Engineering Quality Management Life Sciences or a related field.
Equivalent of 58 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 problemsolving 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 crossfunctional 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 customerfocused solutions for our customers.
What We Offer:
At Tobii Dynavox we believe in empowering individuals including our employees to reach their full potential. Heres what makes us unique:
- PurposeDriven 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 dont have to choose between personal and professional goals.
- Growth and Development: Whether youre 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. Youll feel connected to both your team and our global community.
- A Global Leader with Heart: Be part of an innovative forwardthinking company that combines experience and cuttingedge solutions with a mission to change lives.
Required Experience:
Manager
Employment Type
Full-Time
