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lastModificationDate: 1551792906131

Työnimike: Muu tekniikan erityisasiantuntija

Työnkuvaus:
Job Title: Quality Control Manager
Location: Labsystems Diagnostics Oy, Vantaa, Finland
This position will be responsible for ensuring the timely testing and disposition of raw materials, intermediates and finished products utilizing bioanalytical methods for testing at the Labsystems Diagnostics Oy, Vantaa. The successful candidate will have proven abilities to manage, develop and motivate employees and implement tactical plans to drive sustainable improvements. Assures technical correctness of all testing/value assignment functions to ensure products comply with established internal and external guidelines required to maintain consistent product performance and quality in the field. Provide technical expertise to assure the rapid solution of product and or control system problems. Supervises the timely response to customer complaint investigations including the CAPA plan and customer focus as required.
Job Responsibilities:
Quality assurance - Implementation, Documentation & maintenance of SOPs
Effectively manage ISO- and CE-related certifications, audits, and documentation
Train staff and maintain all statutory and requisite requirements for ISO
Ensure compliance with each country's local authorities' requirements
Provide technical support for product registrations
Manage Regulatory Assurance, Product Registration, and declaration to Health Authorities
Develop qualification plans for changes in existing products or raw materials.
Coordinate the qualification requirements with other QA teams; document the qualification recommendation.
Streamline product release activities and create efficiencies to assure rapid completion of lab testing with a minimum of staff while maintaining technical accuracy and correctness.
Implement practical process improvements to reduce lead times and improve turn-around times for lab testing.
Develop and maintain a flexible organization such that fast changing manufacturing priorities can be accommodated with a minimum of disruption.
Assure that all lab instruments are maintained and qualified.
Assure that software is adequately documented and validated.
Effectively lead projects as assigned.
Plan, perform and evaluate experiments as needed.
Education:
Bachelor's of Science Degree in Chemistry, Clinical Chemistry, Biochemistry, Microbiology or related discipline (Advanced degree preferred)
Experience:
Minimum of 8 years related experience of which five must have been in a proven leadership role.
Previous experience in Diagnostics or Medical Device fields.
Technical background and experience in laboratory
Experience in CE and/or FDA submissions would be an advantage
Knowledge:
Excellent written and oral communication skills - Finnish and English
Team player
Proven ability to influence cross-functional teams without formal authority
Willingness to travel

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2149

positionTypeCode: directhire

Työnantajan nimi: Labsystems Diagnostics Oy

source: TIVA