Limamou Cisse Sow

I work at Integra, located in Le Locle (Switzerland), a company specializing in neurosurgery, particularly in implantable valves for the treatment of hydrocephalus. These devices are crucial in improving the quality of life for patients suffering from this condition. They play an essential role in regulating cerebrospinal fluid (CSF) and managing intracranial pressure, providing an indispensable solution for patients with hydrocephalus.

These devices not only improve survival but also enhance the daily comfort of patients, reducing symptoms such as headaches, cognitive impairments, and motor problems.

My daily tasks are as follows:

- Lead validation of implantable neurosurgical devices (Class III)

- Draft and execute IQ/OQ/PQ protocols, deviation reports, and VMPs

- Perform statistical sampling and DOE for product testing

- Coordinate risk analysis (PFMEA) and test method validations (Gage R&R)

- Interface with QA, R&D, production, and regulatory for audit readiness

- Contributed to ISO and FDA inspection compliance

Define the validation strategy for equipment and plastic injection processes, including FAT/SAT/IQ/OQ/PQ (injection molding machines, molds, and special machines).

Develop an internal training plan to explain the various pharma and medical device qualification stages (FAT/SAT/IQ/OQ/PQ).

Establish a change control strategy with a matrix.

Manage anomalies and deviations: conduct investigations, implement, and monitor CAPAs in collaboration with the development team.

Lead risk analyses.

Oversee change control processes (notification, implementation, and closure).

Review and approve quality documentation and production records.

Support quality visits, inspections, and audits (internal and external).

Contribute to quality system improvement through best practices gained from past experiences.

-Recording/formalising product/process requirements and specifications and the project's technical commitments (external, internal and regulatory customer) until the specifications are approved

-Jointly with the project manager, identify project risks and define the risk removal plan

- Lead the FMEA process internally and with the customer, on the basis of the previously defined synoptic, and monitor the action plan drawn up

- Define the project validation plan

-Monitor the validation plan tests in collaboration with the test technician, supervise the inspection of parts and validate the visual report, monitor the metrology results

- Drawing up protocols and reports for internal and customer FAT, SAT, IQ, OQ and PQ qualifications and monitoring the progress of activities

-Drawing up supplier specifications for components, validating EI parts and the validation file

-Approve specifications for resources

-Participate in project meetings with the customer

- Actively contribute to continuous improvement projects

-Monitor customer relations with regard to quality aspects during the course of the project

-Draw up the production documentation required for series production of the product, train the quality and production teams in the product, controls and packaging

-Participate in the definition and qualification of measurement and control processes

-Ensure the implementation, jointly with the head