Työnimike: Quality Specialist

Työnkuvaus:
Radiometer Turku is part of Radiometer, an international group that designs, manufactures and markets innovative and lifesaving products, solutions and services with a strong brand name within bloodgas and acute care. The strategic focus of Radiometer Turku is Acute Care Diagnostics. Radiometer Turku has 130 employees. Radiometer has over 2500 employees globally and turnover of more than 640 million USD. Quality Specialist, Radiometer Turku, Finland Medical technologies - LEAN procedures - Strong personal impact The main responsibility in the position is improvement and sustainment of QMS documentation, validation, audit and supplier quality management procedures and processes in compliance with regulatory requirements of IVD industry. The responsibilities also include routine tasks related to batch release. The candidate should have at least 5 years of relevant industrial work experience in the quality area. The candidate must be experienced in working with different stakeholders and cross-site. Responsibilities Maintain compliance in quality system documents Develop standard operating procedures Approval of specified documents Validation approvals / Validation Master Plan maintenance Main responsibility of Master Control documentation system and related development work Coordinating internal audits and supplier audits Product release including batch record review for specified products Out-of-specification and non-conformity assessment, approval and closure for specified products Approval of work instructions and specifications for specified products and materials Review of ECR/ECO for specified products and processes Product and process review - report for specified products and processes Approval of Design Transfer related production documents Approval of stability reports for specified products Position Specific Competencies / Experience Education: MSc, Eng or equivalent Certified Lead auditor Fluent in Finnish and English Knowledge of quality management system and regulatory requirements of IVD industry, especially IVD Directive, FDA / QSR At least 5 years of relevant industrial work experience in quality area Deep knowledge of production processes and technologies, including equipment and software Knowledge of immunoassay technologies is an advantage Ability to apply standards and regulations into practice Capacity to structure existing processes and ability to develop new working methods. Understanding of customer needs and processes; especially clinical and laboratory practices Personal Trait Profile Systematic, practical and organized person that is service oriented and able to build relationships, a good team player Able to prioritize and make decisions, structured Experienced working with different stakeholders and cross-site Strong communicational skills, assertiveness and responsiveness Strong problem solving skills Independent, self-motivated and committed

Työnantajan nimi: DHR Finland Oy, Innotrac Diagnostics

Työnantajan osoite: Biolinja 12, 20750 TURKU

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Työn lyhyt kuvaus: Konetekniikan erityisasiantuntijat

Maa: Suomi

Alue: Varsinais-Suomi

Sopimuksen kesto: Tilapäinen

Sopimuslaji: Kokopäiväinen

Lähde työtarjous:
MOL/Työ- ja elinkeinoministeriö, Julkiset työvoimapalvelut, Suomi