Product Quality Compliance Group Leader

E.M.S. - Electro Medical Systems SA

Publication date:
26 January 2023
Workload:
100%
Contract:
Permanent position
Place of work:
Ch. de la Vuarpillière 31, 1260 Nyon

EMS is the leading manufacturer of precision medical devices for dental prophylaxis, orthopaedics and urology. With over 900 qualified and specialised employees, we work on further improving our products and services every day – at our corporate headquarters in Nyon and around the world.

With this philosophy, we are continuing a more than 200-year-old tradition of the Swiss Vallée de Joux. This is where EMS was founded – as well as numerous other brands, which are known around the world for their precision down to the smallest detail.

Product Quality Compliance Group Leader

MISSION

The Product Quality Compliance Group Leader leads the PQC teams within the Quality department in view to the successful Verification and Validation of medical products to support EMS product strategic plans.

As part of the Quality department, the Product Quality Compliance Group Leader supports the team members, Group Leaders and Head of Quality to promote compliance of quality system and EMS products.

RESPONSABILITIES

Lead the PQC laboratory to level of being certified according to ISO17025, develop specific process and knowledge to support the deployment of the most appropriate test to support product compliance
Manage the team of the Product Compliance group and supervise personnel in the correct implementation of work procedures
Responsible for the quality of the documentation related to the tests and external validation
Define & coordinate Verification & Validation activities with respect to user needs, design Input and Outputs in accordance with the project leaders and the general project planning as defined by the management of EMS
Maintain the documentation related to test reports up-to-date and available to all EMS staff
Define and coordinate external validation activities in accordance with the project leaders and the general project planning as defined by the management of EMS
Participate to the creation of SOP of the quality system related to verification and validation activities
Define and coordinate strategic reliability testing plan for any new design project or significant change of existing product in accordance with the project leaders and the general project planning as defined by the management of EMS
Contribute actively in the choice of a technical solution in regard to product reliability and quality in the earliest design phase including definition of associate technical study and test
Analyse the compliance of the developed products or product modifications with regulations

Profil

5 to 10 years of experience in a similar role
Bachelor’s degree / experience in the medical device industry
Experience working for the validation / verification of medical devices
Knowledge of ISO 13485 and ISO 17025
Good oral and written communication skills – ability to work on cross-functional teams.
Good organization skills including planning, follow-up and communication of task status
Self-motivated by working independently and able to take ownership of his/her responsibilities, and to work under time pressure, and to organize various projects in a timely manner.
Ability to interact proactively and provide counsel and expertise to internal and external customers.
Team management: leadership, motivation, fair-play spirit, positive-minded
Fluent in French and English C level

POSITION