What do you want to do?
Are you looking to make an impact in someone’s life, while working in a fast-paced environment?
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.
Where you´ll work:
Tobii Dynavox, part of the Tobii group, 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. We give people a voice. We help people with various disabilities with their hands and their eyes, interact and communicate with technology, in completely new and often game changing ways.
Our Pittsburgh, PA office is located just minutes from “Dahntahn” Pittsburgh and here you will be working with more than 200 happy Tobiians in the most dynamic and friendly environment in all of Pennsylvania. We have everything from design, development, production, and customer service and support right here on site so whatever question you have, you will find the answer in house!
Do you want to make a difference in the lives of our users?Job Description
- Support the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies
- Lead and/or participate in internal audits including scheduling, planning, execution, reporting, and response review and management in a timely manner
- Collaborate with other departments and cross-functional teams on daily tasks and projects, such as CAPA records complaint investigations, and internal audit reports/ responses.
- Work cross-functionally to lead investigations teams and root cause analyses and provide well-documented corrective and preventive action plans for identified issues
- Create and Maintain the Technical Files for the products.
- Ensure that change initiators/reviewers have identified the appropriate employees for process training, and that training is conducted timely and documented appropriately.
- Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union) and Canadian Medical Device Regulations
- Document 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
- Review and evaluate the SRS from quality assurance / Regulatory/Validation.
- Create 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.
- Conduct line failure analysis and trouble shoot production failures
- Evaluate non-conforming material to verify compliance with NCMR and MRB requirements
- Conduct first article of inspection including first time receipts, first time vendors, and revision changes to ensure compliance to standards
- Study process and standard changes to determine impact on Tobii Dynavox products and develop plans to bring materials into compliance
- Manage 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
- Perform various other tasks as assigned
Are you our next Tobiian?
To be successful in this role and at Tobii you need to have an awesome can-do attitude.
We are looking for someone who has:
- Associate Degree or Bachelor’s Degree preferred in the field of electronics or mechanical technology
- 3+ years electronics-related quality assurance or operations experience
- Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, MDD, etc.)
- ASQ Certified Quality Auditor, and/or ISO 13485 Lead Auditor certification preferred
Skills needed to be successful in this position:
- 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
We find it to be a strong merit if you thrive in a fast paced work setting.Additional Information
Please address your questions to Ashley Weiss, firstname.lastname@example.org and submit your resume through our website as soon as possible. Don't wait! At Tobii, we move quickly!
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