QC Officer

Quality Control Officer
Job description
About the company

Labsystems Diagnostics Oy is leading and innovative company that specializes in the development, manufacturing and the sales of in vitro diagnostic tests globally. The company is based in Finland and has over 40 years experience in pioneering cutting edge technologies for newborn screening and point of care testing. These tests are underpinned by several technologies such as Fluorescence enzyme immunoassay (FEIA), Point-of-Care lateral flow immunochromatographic, mass spectrometry (LC-MS/MS), HPLC and Molecular diagnostics. We are looking for a Quality Control Officer to lead our QC department.

Role description & core Responsibilities
Responsible for overseeing the quality control program for our MDx, FEIA, POCT and LC-MS/MS in vitro diagnostic products.
Lead and manage the daily operations of the QC team, including inspections, testing, Lot history approval and audits.
Develop, implement, and maintain quality control policies and procedures.
Testing approval of Incoming Raw Material (RM), Semi-Finished Goods (SFG) and Finished Goods (FG).
Work closely with production, regulatory and QA teams to ensure product specifications fulfillment as well as product compliance/performance.
Regular reporting of quality control activity to management and production teams.

Required experience and qualification
Masters degree in Biological science or related disciples.
4+ years` experience in quality control, QA or manufacturing within the IVD industry.
Knowledge and previous hands on experience in immunoassays (ELISA, POCT) and molecular diagnostics test/ technologies.
Experience and knowledge of quality standards and regulation for in vitro diagnostics such as ISO13485, IVD-R, MDSAP.
Excellent written and verbal communication skills in Finnish and English.
Experience in leading and managing technical teams.
What we offer
Opportunity to work in an innovative company within a friendly and inspiring environment.
An inspiring opportunity to work and learn from experienced and friendly colleagues.
Competitive salary and benefits.

For further information and application
Send CV to Kevin Eboigbodin, email; kevin.eboigbodin@labsystemsdx.com by 31st October 2024. The position will be filled once a suitable candidate is found

Tagged as: Industrial production & manufacturing