Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help tackle some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Our Finland locations include Vantaa and Joensuu, employing over 800 professionals in R&D, production, supply chain, quality, marketing, sales, and administrative support. We hire experts in different fields including engineering, chemistry, microbiology, and bioinformatics. Our Vantaa site develops laboratory automation solutions, clinical chemistry and industrial chemistry analyzers and assays, food safety kits, pipettes and other diagnostics and research solutions. It is conveniently located close to the Vantaankoski railway station. Please read more about Finnish sites, innovative work, and collaborative colleagues at https://jobs.thermofisher.com/global/en/finland.

• Support R&D in Design Control: Act as the QA team representative by reviewing and approving project plans, product requirements, risk analyses, verification, and validation plans and reports.
• Lead QA Discussions: Guide and lead project discussions from a QA perspective. Ensure new products meet regulatory requirements, customer needs, and product requirements. Ensure that procedures and processes are followed.
• Supplier Selection: Assist in selecting suppliers for new products by participating in quality agreement creation.
• Approve Engineering Change Orders: Review and approve ECOs to ensure requirements are met and design control elements are applied.
• Support PDP and Sustaining Activities: Train and guide development teams to align with quality system requirements, applicable ISO standards, guidelines, and regulations. Develop, interpret, and build written Standard Operating Procedures (SOPs) and Working Instructions (WIs).
• Establish Networks: Establish and maintain a network of internal and external contacts for project collaboration to successfully implement quality measures.
• Conduct Audits: Conduct internal and external supplier audits and support internal and external audits.

• A degree in Chemistry, Chemical Engineering, or a related field, or equivalent experience.
• Experience in a quality assurance role, specifically in the field of analytical instruments or assays.
• Strong understanding of regulatory requirements, ISO standards, and quality system regulations like ISO13485, ISO9001, EU IVDR/IVDD, or FDA QSR.
• Excellent communication and collaboration skills, with the ability to lead discussions and influence project outcomes.
• Impressive attention to detail and the ability to build flawless documentation and reports.
• Strong analytical and problem-solving skills.
• Experience in conducting supplier audits and internal audits is highly desirable.