Job Description

　　Thermo Fisher Scientific is the world leader in serving science, with annual revenue exceeding $40 billion. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.

　　This position is based in Uppsala, where Thermo Fisher develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,900 employees worldwide, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics.

　　The job

　　The Design Quality Assurance Specialist will be part of Product Quality Management team. The essential tasks for the team is to assure that the Risk Management process is developed and maintained and that Product Development activities are performed in compliance with our Quality System as well as with applicable Regulations and Standards. The team is also responsible for the Post Market Surveillance process.

　　The Design Quality Assurance Specialist will work in a cross-functional environment and work closely with Project Managers and the R&D teams by representing Quality Assurance in Product Development Projects and work on process improvements.

　　You will be expected to drive improvements and a successful candidate will show attitude and examples showcasing that continuous improvement comes naturally.

　　What will you do?

　　Assure Quality Planning in product development projects.

　　Provide guidance for application of Design Control i.e. Design and development planning, Design input (e.g. specifications), Design reviews, Product verification and validation, Risk management, Usability engineering and Design transfer etc.

　　Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.

　　Provides support to post market design changes, including assessment of proposed changes using design control methods.

　　Participate in or lead the completion and maintenance of risk analysis related to product development and quality systems.

　　Participate in or lead the completion and maintenance of Post Market Surveillance activities, such as data gathering and reporting.

　　Participates in team projects and assignments, facilitating or leading teams as necessary.

　　Identifies the opportunities for continuous improvement of the Quality Systems.

　　Provide Quality System expertise to the organization and ensure compliance to applicable Quality System Regulations by supporting interpretation of regulations, performing gap analysis and lead activities to implement improvements.

　　Support investigations and resolve Quality System non-conformities (defined during internal and/or external audits).

　　Train personnel on Quality Management System related topics.

　　What do you need?

　　A university degree in medical/technical sciences and significant experience from Quality Management Systems in an IVD/Medical device environment, e.g. QSR, EU medical device directive, ISO 13485, etc.

　　Experience in Risk Management and Design Controls.

　　Strong Leadership capabilities, process and customer focused

　　Strong interpersonal skills, driving cross-functional collaboration

　　Ability to organize work, can decide about and reach objectives for projects and the processes

　　Strong analytical problem solving skills

　　Strong ability to drive tasks/projects to closure in a timely fashion

　　Excellent verbal/written communication skills in Swedish and English

　　Experience of working in an international organization and be used to building long term strategies related to Quality

　　Apply today!

　　Please send in your application, including a cover letter, CV (in one document) in English by 31st January 2024. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of sex, transgender identity or expression, ethnicity, religion or other belief, disability, sexual orientation or age on, or other non-disability related technical issues will not receive a response.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.