Head of Quality
il y a 3 semaines
Publication date
21 August 2024
Location
Mechelen
Country
- Belgium
Workplace type
Hybrid
Travel percentage
5%
Function type
Full-time
Contract type
Employee
Experience required
- Minimum 15 years of experience in healthcare industry of which minimum 10 years in Quality.
- Profound experience of medical device and/or In Vitro diagnostics development and manufacturing in FDA regulated environment. (PMA level products).
- Solid experience with FDA inspections.
Education
- Academic level in engineering, chemistry, pharmacy or equivalent through experience.
HEAD OF QUALITY (MEDTECH OR IVD EXPERIENCE REQUIRED)
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 Control and Quality Assurance activities related to the Design, Development, Manufacturing, Testing, Release and Customer related process for Biocartis Products and of the incoming Quality Control.
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**
The role includes, but is not limited to, the following accountabilities:
**General**
- Ensure that quality system requirements are effectively established and effectively maintained in accordance with applicable standards and regulations. Ensures maintenance of the applicable QMS certification.
- Ensure that products that are developed, manufactured, released, distributed and services at/from all Biocartis facilities consistently comply with the policies, procedures, work instructions and specifications as covered by the Quality Management System. Accountable for strategic development of the functional area to serve short-, mid
- and long-term business needs, and the implementation thereof.
- Acts within joint accountability as the Person Responsible for Regulatory Compliance (Article 15; IVDR regulation) Person Responsible for Regulatory Compliance in accordance with IVDR, article 15, paragraph 1-4, specifically for the responsibilities defined in sub-paragraph 3 a and 3 c:
a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
c) the post-market surveillance obligations are complied with in accordance with Article 10(9);”, which states: “Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 78”.
- Champions 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. This includes but is not limited to:
i. audits from partners, customers, Regulatory authorities and notified bodies;
ii. timely release of components and Biocartis products to agreed specifications and in compliance with approved regulatory files.
- Accountable for ensuring best-in-class resource, on-time and in-scale (human) resource availability according to short-, mid
- and long-term business demands.
- Accountable for ensuring best-in-class performance of the quality management functional area.
- Accountable for ensuring streamlined interfaces (e.g. processes) of the functional area quality management to other functional areas involved in the quality management process.
- Accountable for financial objectives and annual budgets of the functional area quality.
**Resource and competence management**
- Ensures lean organizational approach while continuously striving for minimum overhead of the functional area without compromising its effectiveness.
- Creates an environment of strong team spirit, sense of urgency and high motivation within the team.
- Accountable for staffing decisions including hiring, promotions and termination by evaluating performances of employees.
- Is an inspirational coach and mentor for the team, encouraging job satisfaction and people’s personal growth; enhances professionalism.
- Maintains the quality competence manageme
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