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Quality System Engineer

Tobii Dynavox, named a Top Workplace, is the world leader in eye tracking and speech generating devices - products that help individuals with speech and motor impairments live a richer and more independent life. Headquartered in Stockholm Tobii covers a global market with offices in USA, Germany, Norway, Japan and China. If you want to work with meaningful products and solve interesting problems, we might be the right company for you!

Quality System Engineer

We give people a voice. We help people with various disabilities “speak” with their hands and their eyes, interact and communicate with technology, in completely new and often game changing ways. Have a look at our users Steve , Katie , and Stephen to get an idea of how our products can completely change people’s lives. Every day we help people with disabilities ranging from ALS and Cerebral Palsy to Spinal Cord Injury and Stroke.

The Quality System Engineer analyzes and evaluates material failures including finished product, changing processes, or product-based analysis, review of applicable regulatory requirements and developing action plans for compliance are essential components of this position. The person understands the principles of product and service quality evaluation and controls and taking responsibility for the quality of a company's products.

The role and responsibilities

In this role, you will be responsible for/work with:

  • Supporting the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies
  • Leading and/or participating in internal audits including scheduling, planning, execution, reporting, and response review and management in a timely manner
  • Collaborating with other departments and cross-functional teams on daily tasks and projects, such as CAPA records complaint investigations, and internal audit reports/ responses.
  • Working cross-functionally to lead investigations teams and root cause analyses and provide well-documented corrective and preventive action plans for identified issues
  • Creating and maintaining the Technical Files for the products.
  • Ensuring that change initiators/reviewers have identified the appropriate employees for process training, and that training is conducted timely and documented appropriately.
  • Maintaining the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union) and Canadian Medical Device Regulations
  • Documenting all corrective and preventative actions taken to address failures and bring products/materials into compliance
  • The Quality Engineer will perform root cause analysis on clinically applied medical device global customer returns to ensure high levels of quality, reliability, safety, and efficacy.
  • Additional responsibilities include independently coordinating the investigation process with Engineering and/or Research and Development. The results of these analyses will be formally documented and incorporated into written customer communications
  • Reviewing and evaluating the SRS from quality assurance / Regulatory/Validation.
  • Creating HW test plan based on the SRS and conduct the tests with the Research and Development (RnD) team in different stages in the design process.
  • Conducting line failure analysis and trouble shoot production failures
  • Evaluating non-conforming material to verify compliance with NCMR and MRB requirements
  • Conducting first article of inspection including first time receipts, first time vendors, and revision changes to ensure compliance to standards
  • Studying process and standard changes to determine impact on Tobii Dynavox products and develop plans to bring materials into compliance
  • Managing the calibration schedule and vendor management for the calibrations, including the logging and documentation of the SOPs.
  • Filing of reports and to PLM/PDM Systems
  • Quality System Management Review with QMS-manager
  • Performing various other tasks as assigned

All our jobs at Tobii are about innovation, passion and not the least- making things real.

We are looking for someone who has:

  • High School Diploma
  • Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, MDD, etc.).
  • Associate Degree or some technical training in the field of electronics or mechanical technology
  • 5+ years electronics-related quality assurance or operations experience

Skills needed to be successful in this position:

  • ASQ Certified Quality Auditor, and/or ISO 13485 Lead Auditor certification preferred
  • Ability to communicate technical and business requirements by means of oral and written communication
  • Able to communicate at all levels within an organization
  • Basic analytical, trouble-shooting, and problem-solving skills.
  • Strong interpersonal and teaming skills
  • Proficient in MS Office Word, Excel, and Outlook
  • Detailed oriented

At Tobii, we believe that diversities are what strengthen us. Regardless if you walk around in high heels or prefer to go barefoot; if you’re a huge gamer or if you haven’t played a game since Pacman was released; if Pittsburgh is your where you grew up or if your roots are somewhere else. It is the pride and happiness in what we do that make us come together. Welcome to Tobii!

Apply as soon as possible by our website. We handle applications ongoing, don't wait! At Tobii Dynavox, we move quickly.

Tobii Life

Working at Tobii you will find yourself in an innovative environment and work with passionate colleagues from all around the world. Our technology brings a voice to people with speech impairments, it helps us understand human behavior and it is revolutionizing the way we interact with technology.

If you want to build a company rather than just work for one, if you take pride in honest hard work and want to perform freely in an open environment where you can be yourself, you will feel right at home.

It’s all about innovation, passion and making things real.

Tobii Dynavox values equality of opportunity, human dignity, and racial/ethnic and cultural diversity. Tobii Dynavox does not discriminate against individuals on the basis of race, color, sex, sexual orientation, gender identity, religion, disability, age, veteran status, ancestry, or national or ethnic origin.

Equal Opportunity Employer/AA Women/Minorities/Veterans/Disabled

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The Tobii way

Tobii is an international company that nurtures a welcoming, friendly atmosphere and non-hierarchical mindset. In Europe, North America and Asia, we cultivate a culture where we all can be ourselves and anyone can talk to anyone, share thoughts and discuss new ideas. This creates an atmosphere where we are more work buddies than colleagues. And the same way that we care for each other on a personal level, the company cares for us as employees; offering work-life balance and great benefits. All this combined spurs career opportunities, innovative ideas and – equally important – fun at work.

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