Product Quality Compliance Group Leader
vor 3 Wochen
Responsibilities
- 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
- Maintain the documentation related to test reports up-to-date and available to all the staff
- Define and coordinate external validation activities in accordance with the project leaders and the general project planning as defined by the management
- 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
- 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
Profile/background
- 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
Languages Skills:
- Fluent in French and English C level
Type d'emploi : Temps plein
Programmation:
- Travail en journée
Lieu du poste : Un seul lieu de travail
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