Global Quality Management System Manager
Global Quality Management System 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 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 support projects in quality compliance matters.
You will be part of our global Quality Assurance and Regulatory team as a responsible for Group Quality Certificates and Subject Matter Expert for NonProduct 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 riskbased 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 realtime 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 Intracompany 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 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.
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.
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 riskbased 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 nonproduct software validation (NPSS).
Strong problemsolving and analytical skills to identify potential quality risks providing actionable recommendations and report on key process performance metrics to senior leadership.
Crossfunctional 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. We look forward to hear from you!
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:
Exec
Employment Type
Full-Time
