As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 20 billion in annual revenue. 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. At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.
In Finland we have over 800 employees in Vantaa and Joensuu. We employ experts in several different functions such as production, instrument and reagent manufacturing, R&D, marketing, sales, quality, support functions and supply chain. We hire experts in different engineering fields, chemistry, microbiology and bioinformatics. Vantaa site is located close to the Vantaankoski railway station. Our extensive range of products developed and manufactured in Finland includes pipettes, microplate instruments, magnetic particle processing systems as well as clinical chemistry and industrial chemistry analyzers, laboratory automation solutions and food safety kits.
Please find more information on www.thermofisher.com
QA Engineer/Chemist, Clinical Diagnostics Systems, Clinical Mass Spectrometry
Thermo Fisher Scientific is currently recruiting a Quality Engineer/Chemist to be part of QARA Team based in Vantaa, Finland.
We are looking for a Quality Engineer/Chemist with a background in analytical chemistry, biochemistry, clinical chemistry, engineering or related field. Ideally, you have solid experience of international quality system requirements and regulations of in vitro diagnostic medical devices.
QA Engineer’s/Chemist’s responsibility is to support, improve and maintain compliance to specifications and quality system regulations of liquid chromatography – tandem mass spectrometry (LC-MSMS) methods for the Cascadion SM Clinical Analyzer during product development and after the release for sales.
We are looking for a proactive, self driven, result oriented team player. You enjoy working with high technology products and driving multiple initiatives at the same time. You want to develop yourself and the way of working. We offer motivating tasks in innovative and international working environment. Thermo Fisher Scientific will provide you with an environment of challenging work, growth and development through the course of your career.
- Work as an integral part of Thermo Fisher’s Clinical Diagnostics Systems business and as part of QARA team at Vantaa site
- Responsible of Quality Assurance for IVD LC-MSMS quantification methods on Cascadion SM Clinical analyzer.
- Reviewing and approving project plans, risk analysis, verification & validation plans/reports, and transfer plans/reports as the QARA team representative, particularly in the own area of responsibility (documentation related to liquid chromatography – tandem mass spectrometry (LC-MSMS) methods for the Cascadion SM Clinical Analyzer)
- Supporting product development phase activities by training and giving guidance to development team to comply to quality system requirements, applicable standards and regulations
- Follow, interpret and create written Standard Operating Procedures (SOP’s) and Working Instructions (WIs).
- Act as Subject Matter Expert (SME) and advisor in area of expertise
- Establish and maintain network of internal and external contacts for project collaboration
- Execute activities in accordance with agreed schedules and budget
- Perform cross-departmental internal and external audits
- Supports continuous product and process improvement. CAPA review and coordination for customer complaints and internal non-conformities
Qualifications and skills needed to be successful:
- M.Sc (or equivalent) degree in analytical chemistry, biochemistry, clinical chemistry, engineering or related field and minimum 2 years of experience of working in in vitro diagnostic industry (or other regulated environment), or alternatively
- Bachelors Degree in relevant field with 5 years of experience of working in in vitro diagnostic industry (or other regulated environment)
- Previous experience with quantitative bio-analytical sample preparation and LC-MSMS technology, equipment, method development and validation, data analysis and software is preferred.
- Experience from working with quality system requirements to worldwide markets, especially Europe and USA
- Skill set in conducting discussions with international partners
- Excellent verbal and written communications skills in English
- Experience in applying various statistical principles to sample size determination and result assessments
- Attention to detail in setting, conducting, and documenting; records keeping in compliance with company policy and regulatory requirements (e.g. IVD Directive and USA FDA QSR; ISO 13485)
- Ability to communicate efficiently with the experts in the other scientific and technical fields, and a willingness to learn new skills
- Ability to reach solution with confidence and integrity
We look forward to receiving your application, including a cover letter and CV and a salary request in English. Please apply via http://jobs.thermofisher.com/. Reference: 61871BR
Should you have any questions, please contact QARA Manager, Maija Numerla +358 40 584 5921 on Feb 7 from 10 to 11 a.m. and Feb 14 from 10 to 11 a.m.
Please apply by the 19th of February.
The position is filled as soon as a suitable candidate is found.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.
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.
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