Head of Quality

vor 3 Wochen

Lausanne, Schweiz LHH Vollzeit

**Head of Quality - Medical devices - Vaud**

For one of our clients, a medical devices company based in Canton de Vaud, LHH Recruitment Solutions is recruiting a **Head of Quality in Medical Devices**.

The Head of Quality will be responsible to manage **Quality Assurance, Quality Control** and **Quality **support to manufacturing, Validation teams and on-site Regulatory Affairs for the company.

Your responsibilities as a **Head of Quality** will be (but is not limited) to:
Be responsible for overseeing all quality assurance efforts, including the adherence of a quality assurance program according to applicable regulations and assure quality products and process control by establishing and enforcing quality standards, testing materials and product.

Act as the Quality Management Representative for activities and Person Responsible for Regulatory Compliance (PRRC) as required by the European Medical Devices Regulation EU MDR 2017/745.

Maintain Global Quality Management System in accordance with the standards and regulatory requirements.

Manage and provide strategic planning for the analysis, evaluation and other information concerning factors such as complaint trends, and design and development of new products for consideration by other members of management team, including conducting regular Management Review meetings

Develop, conduct, control and monitor processes to ensure that product conforms to its specifications.

Mentor to Quality teams (definitions of objectives, performance evaluation, etc.) and ensuring a level of training and skills appropriate to the requirements.

Monitor quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed.

Be Partners with R&D, Operations, Clinical & Marketing to assure there is appropriate execution of design controls and process validation.

Participate in strategic decisions concerning the Organization and the achievement of the objectives of the quality organization.

Manage Departmental Budgets in accordance with approved targets

Manage a team

**Profile**:
Higher education scientific; Bachelor’s degree or equivalent, Master’s Degree Preferred

Minimum 10 years of proven experience in the field of medical devices

Knowledge in-depth of ISO 9001&13485, QSR 21CFR820 and MDSAP.

Experience in Notified Body and FDA inspections

Solid experience in problem solving and statistics

Fluent in English and French

Ability to interact with a variety of people, internal and external to the company with different cultures.

Listening and availability, capacity for analysis, force of proposal and decision making

BOOST

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