Quality TechnicianExperience Level: Mid Level | Posted Date: 2025-04-14
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.
To learn more about what we make possible, meet some of our customers or take a look at some of our solutions.
As a Quality Technician, you will join a global team that ensures delivery of safe and effective medical devices to our customers. Your role will include leading and executing quality operations across production, repairs, and rentals. While ensuring compliance with the regulatory requirements and internal standards, you will contribute to continuous improvement, and drive operational excellence.
Please note: This is an onsite role from our office in Stockholm city. This role can include occasional travel (2 times a year), which would be communicated in advance.
In this role, you will:
Quality Control & Inspection
Perform and oversee day-to-day quality control activities, including Incoming Quality Control (IQC) and in-process inspections of medical devices.
Investigate and resolve non-conformances and deviations in production, repairs, and rentals.
Oversee equipment calibration schedules and ensure tools used in production and repairs meet calibration and regulatory standards.
Quality Improvement & Risk Management
Lead or support Corrective and Preventive Actions (CAPA), including root cause analysis and effectiveness checks.
Analyze production and service data trends to recommend and implement quality improvements.
Conduct risk assessments and Process FMEA (pFMEA) to identify and mitigate quality and operational risks.
Lead or contribute to Lean and Kaizen initiatives focused on continuous quality improvement.
Compliance & Audits
Assist in audit readiness, support internal audits, and maintain compliance with ISO 13485 and MDR.
Participate in process change control and support cross-functional quality projects.
Documentation & Training
Develop, update, and implement Standard Operating Procedures (SOPs), inspection protocols, and work instructions.
Provide training to production and repair personnel on quality procedures and control points.
Validation & Process Control
Support validation activities, including data collection and development of validation protocols (IQ/OQ/PQ).
What We're Looking For:
We are looking for someone that has:
Equivalent of Bachelor’s degree in relevant technical disciplines such as Engineering, Life Sciences.
Equivalent of minimum 3 years of experience in Quality roles within a regulated environment, preferably in medical devices or electronics.
Familiarity with electronic test equipment, inspection tools, and calibration systems.
Knowledge of ISO 13485, MDR, and ISO 14971.
Experience using ERP systems (e.g., Dynamics 365) and Quality Management (QMS) systems.
Excellent communication, problem-solving, and analytical skills.
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.
At Tobii Dynavox, we believe in empowering individuals – including our employees - to reach their full potential. Here’s what makes us unique: