Head of Quality (Medtech or IVD experience required)

at  Biocartis

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:

EDUCATION

Academic level in engineering, chemistry, pharmacy or equivalent through experience.

EXPERIENCE

• Min. 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. (PMA level products).
• Solid experience with FDA inspections.

TECHNICAL/THEORETICAL KNOWLEDGE, SKILLS AND EXPERTISE

• Experience in the medical devices and/or in the IVD industry;
• Experience with US regulatory applications, as well as Europe; Asia is a plus;
• Experienced at maintaining focus on the bigger picture whilst also maintaining detailed analysis as and when required;
• Confidence to make decisions and assist others in doing so, even when complex and difficult;
• Hands on mentality;
• Thrives in a fast paced and changing environment;
• Proven leadership capabilities with a track record of managing across different disciplines within areas of high risk, uncertainty and familiarity with the specific needs of molecular and diagnostics programs;
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a management team member and to engage and influence team members in a matrixed environment;
• Excellent communication skills to share the strategy, deliverables and action plans of all projects;
• Able to drive forwards all quality management visions and initiatives and align them with the requirements of business and regulatory requirements;
• Strong business acumen: thorough understanding of e.g. P&L, NPV;
• Excellent presentation and business writing skills.

• Provide strategic leadership for the company’s Quality Management System in accordance with worldwide (EU, US, and ROW) regulatory requirements;
• Act as management representative conform ISO13485 and 21CFR820