Quality Manager

Job description

The Quality Manager is responsible for all quality matters and quality improvements activities within EMS. The Quality Manager is responsible for results in terms of product quality and compliance with internal/external regulations and standards (ISO 9001,ISO13485, FDA QSR 21 CFR 820,…)and with EMS policies.

The Quality Manager will be in charge of:

• Defining, planning and prioritizing quality improvements activities ; developing and improving all quality systems; develop improvements tools such as statistics, KPIs, etc
• Ensuring compliance with internal/external regulations and policies including good manufacturing practices and the development of solid relationships with the competent authorities.
• Ensuring the management and filing of all company data related to the quality
• Organizing and preparing the Management reviews
• Analyzing the Cost Of Quality (COQ)
• Providing support to all departments concerning quality issues
• Training and informing the company concerning the evolution of the Quality Management Systems
• Planning, organizing and managing third party audits (ISO 13485, FDA…) and internal and suppliers audits
• Coordinating activities such as correctives actions and improvements plans
• Influencing and supporting the Quality Assurance and Control functions to ensure a continuous quality as well as the assurance of product safety and efficacy
• Ensuring that all equipments and processes are maintained in an up-to-date and validated state
• Managing a team of 22 including 6 direct reports

The department regroups four groups: Regulatory affairs, Quality (QMS, audits..), Documentation and Industrialization.

Today, the industrialization group is, additionally to its involvement of new products development, the technical arm of the quality manager to improve the quality of our products during their lifecycle. Thus, the quality manager is also, in our current organization, empowered to supervise the implementation of technical solutions. As such the quality manager supervises :

• The execution the control and coordination of new products
• The implementation of technical solutions related to product complaints and internal change requests

Profile required

• University degree in a scientific/engineering discipline (EPFL, ETS or equivalent degree).
• Open-minded and communicative person; “entrepreneur” spirit, outstanding communications skills and charisma.
• Flexible and solution-oriented personality. Strong analytical and problem-solving approach, team-work oriented and having a strong customer orientation.
• At least 4-5 years experience in a similar position including experience with GMP, ISO and GxP regulations, an experience in the medical device field would be a solid advantage, 2-3 years experience in management, experience in conducting audits.
• Fluent in English and in French required; any other European language knowledge will be a plus.

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