· Accountable and responsible for development of functional laboratory test methods, implementation and validation for design control, incoming control testing and clinical release testing.
· Provide sound functional test method validation expertise and validation procedures.
· Define, procure and qualify equipment required for the test methods in partnership with suppliers.
· Create validation protocols and reports in compliance with applicable procedures, write test methods instructions and execute all qualification, validation Participate in design verification protocols, self-execute all tests accordingly.
· Create and maintain laboratory notebook and raw data compilation supporting any reports in compliance with data integrity requirements.
· Perform statistical analysis of all test data and report and actively participate in product failure analysis arising during testing.
· Effectively collaborate with quality and technical project functions and communicate tests results outcome and issues promptly.
· Ensure compliance with all local, state, federal, and Idorsia quality policies, procedures and practices, safety regulations, policies, and procedures.
- Test Equipment:
· in collaboration with the Product technical experts, quality engineering, and suppliers (where appropriate), define equipment required for each test methods, procure and qualify equipment including protocols and reports writing.
· Create the equipment calibration and maintenance plan.
- Test Methods development and validation:
· Elaborate/Develop test methods required by product functions to test.
· Procure and control test method fixture to requirement
· Create test method validation protocol and acceptance criteria (variable data or attributes), procure tests parts, execute test method validation and write associated report.
· Transfer method from/with suppliers including equivalency tests method statistical criteria for qualification and validation and execute transfer.
· Write test method instructions.
- Testing execution:
· Manage Product storage and pre-conditioning required prior to testing
· Perform all functional test internally and support testing with service Providers for sub-contracted tests.
· Complete statistical analysis to acceptance criteria and write reports.
· Create and Maintain a laboratory notebook and ensure raw data integrity and accuracy using a four-eyes principle. Analyze any test failure, demonstrating if it is test method related or product related. Where product related, collaborate pro-actively with technical expert for investigations and resolution.
- Required Skills
Leadership and Engagement
· Guarantee the quality of testing and accuracy of reported data.
· Ensure method validation prior to testing execution.
· Maintain equipment and tools calibrated and in a state of the art condition
· Self-perform all internal tests.
- Leadership courage
· Demonstrate and promote leadership courage by doing what is right. Instill confidence to team in the reliability of testing.
· Technical and personal skills: Meticulous with particular attention to details for validation and testing.
- Desired Qualifications
· Demonstrated functional test validation expertise for both variable and attribute test methods
· Demonstrated laboratory equipment and control knowledge and compliance to GLP
· Advanced skills in method validation Advanced statistical knowledge (e.g. use of minitab or the like, ability to use non normality transformation for statistical analysis...)
· Preferably knowledge of Medical Device ISO standard test method (ISO 11040, 11608...)
· Team orientation
· Strong motivational fit
· Minimum 7 years of experience in laboratory functional testing, laboratory equipment qualification and maintenance and statistical hands-on practices for medical devices or Combination product testing