Social network you want to login/join with:Head of Quality (Medtech or IVD experience required)Client:BiocartisLocation:Mechelen, BelgiumJob Category:OtherEU work permit required:YesJob Reference:9ac572224352Job Views:4Posted:17.03.2025Expiry Date:01.05.2025Job Description:The Head of Quality is accountable for the functional area of quality. The Head of Quality is responsible for the company’s global strategic direction, development, implementation and operational management of all Quality Assurance activities related to the Design, Development, Manufacturing, Testing, Release and Customer related processes for Biocartis Products.He/She will serve as the key point of contact representing Quality in various governance bodies and is accountable for proper liaising with various regulatory agencies for quality related matters.He/She is an expert in one or more domains of quality. He/she leads the strategy development and operational aspects of the functional area quality and is accountable for Biocartis' processes owned by the functional area quality, and manages the financial objectives of the functional area quality.The Head of Quality is accountable for all people management aspects within the functional area of quality. He/she ensures that the quality teams are equipped with strong people, and is accountable for the team’s talent and competence management.He/She is an active and visible change agent, exposing inspirational leadership across the team to achieve the Biocartis goals in the immediate and longer term.ACCOUNTABILITIESEnsure that quality system requirements are effectively established and maintained in accordance with applicable standards and regulations.Ensure that products developed, manufactured, released, and distributed comply with the policies, procedures, work instructions, and specifications covered by the Quality Management System.Act within joint accountability as the Person Responsible for Regulatory Compliance (Article 15; IVDR regulation).Champion the development and maintenance of a Quality Culture within Biocartis.Accountable for leading all operational aspects of the function while continuously striving for performance improvement and effectiveness.Accountable for ensuring best-in-class resource availability according to business demands.Accountable for financial objectives and annual budgets of the functional area quality.Resource and competence managementEnsures lean organizational approach while continuously striving for minimum overhead.Creates an environment of strong team spirit and high motivation within the team.Accountable for staffing decisions including hiring, promotions, and terminations.Is an inspirational coach and mentor for the team.Maintains the quality competence management and succession plan in line with team and business needs.Process ownershipEnsures compliant, efficient & effective quality processes.Acts as the most senior spokesperson within Biocartis representing the Quality Organization.Ensures appropriate problem solving within the functional area and projects.PROFILE REQUIREMENTSEducationAcademic level in engineering, chemistry, pharmacy or equivalent through experience.ExperienceMin. 15 years of experience in healthcare industry of which min. 10 years in Quality.Profound experience of medical device and/or In Vitro diagnostics development and manufacturing in FDA regulated environment.Solid experience with FDA inspections.Technical/theoretical knowledge, skills and expertiseExperience in the medical devices and/or in the IVD industry.Experience with US regulatory applications, as well as Europe; Asia is a plus.Proven leadership capabilities.Software and database applicationsMS Office (Excel, PowerPoint, Word and Outlook)Legislation and regulationISO 13485 and CFR 820 deep knowledge.LanguagesFluent in English (written and spoken), any other European language is considered an asset.Our offeringWe offer you a truly exciting job in a senior leadership role in a fast-growing international and innovative environment. You will have freedom to shape your work and shape your job where you deem it necessary.Of course we offer you an appropriate compensation package which includes a Flexible Income Plan & a hybrid way of working to maintain a healthy work/life balance.
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