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Head of Quality (Medtech or IVD experience required)
Client:
Biocartis
Location:
Mechelen, Belgium
Job Category:
Other
EU work permit required:
Yes
Job Reference:
9ac572224352
Job Views:
4
Posted:
17.03.2025
Expiry Date:
01.05.2025
Job 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.
ACCOUNTABILITIES
1. Ensure that quality system requirements are effectively established and maintained in accordance with applicable standards and regulations.
2. Ensure that products developed, manufactured, released, and distributed comply with the policies, procedures, work instructions, and specifications covered by the Quality Management System.
3. Act within joint accountability as the Person Responsible for Regulatory Compliance (Article 15; IVDR regulation).
4. Champion the development and maintenance of a Quality Culture within Biocartis.
5. Accountable for leading all operational aspects of the function while continuously striving for performance improvement and effectiveness.
6. Accountable for ensuring best-in-class resource availability according to business demands.
7. Accountable for financial objectives and annual budgets of the functional area quality.
Resource and competence management
1. Ensures lean organizational approach while continuously striving for minimum overhead.
2. Creates an environment of strong team spirit and high motivation within the team.
3. Accountable for staffing decisions including hiring, promotions, and terminations.
4. Is an inspirational coach and mentor for the team.
5. Maintains the quality competence management and succession plan in line with team and business needs.
Process ownership
1. Ensures compliant, efficient & effective quality processes.
2. Acts as the most senior spokesperson within Biocartis representing the Quality Organization.
3. Ensures appropriate problem solving within the functional area and projects.
PROFILE REQUIREMENTS
Education
Academic level in engineering, chemistry, pharmacy or equivalent through experience.
Experience
1. Min. 15 years of experience in healthcare industry of which min. 10 years in Quality.
2. Profound experience of medical device and/or In Vitro diagnostics development and manufacturing in FDA regulated environment.
3. Solid experience with FDA inspections.
Technical/theoretical knowledge, skills and expertise
1. Experience in the medical devices and/or in the IVD industry.
2. Experience with US regulatory applications, as well as Europe; Asia is a plus.
3. Proven leadership capabilities.
Software and database applications
MS Office (Excel, PowerPoint, Word and Outlook)
Legislation and regulation
ISO 13485 and CFR 820 deep knowledge.
Languages
Fluent in English (written and spoken), any other European language is considered an asset.
Our offering
We 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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