Quality Control Manager
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 Manager to lead our QC department.
Job Description
Role description & core Responsibilities
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.
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.
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.
Jätä hakemus: https://tyomarkkinatori.fi/henkiloasiakkaat/avoimet-tyopaikat/05b28d47-2...
Yhteystiedot: Please send your application by email to
[email protected]
Työpaikan osoite: Tiilitie 3, 01720 Vantaa
Työ alkaa: Työskentely alkaa mahdollisimman pian
Työaika: Kokoaikatyö
Työn kesto: Toistaiseksi voimassa oleva
Hakuaika päättyy: 06.09.2024 15:00
Ilmoitus jätetty: 27.08.2024 12:32
Työmarkkinatorin ilmoitusnumero: 05b28d47-21d8-45a8-88ae-6d94d8c39f84
Lähde: Työmarkkinatorin asiakastietojärjestelmä
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Vantaa

Kokopäiväinen, Vakituinen