Verification Engineer with Expert Knowledge in Statistics Device Devel

VERIFICATION ENGINEER WITH EXPERT KNOWLEDGE IN STATISTICS DEVICE DEVELOPMENT,

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Our client a pharmaceutical company in Basel is looking for a Verification Engineer with expert knowledge in statistics Device Development, Biologics Europe.

SPECIFIC RESPONSIBILITIES

- Translate cGxP and normative requirements (eg, USP, Ph. Eur., ISO, ASTM) into practical lab processes (eg test sample management, test method validation and transfer, discrepancy management and OOS, training, change management, complaints) including practical development, implementation, documentation.

THIS INCLUDES IN DETAIL:

- Develop robust test method validations
- Define appropriate statistical techniques and acceptance criteria (Gage R&R)
- Author of protocols, rationales and reports
- Perform Risk Assessment/FMEA

Lead and track Change Control activities for Test Methods and Lab Processes, Assess impact of changes (internal or external) on test method validation and compliance of existing lab processes Lead or support transfer of methods into clinical and commercial facilities/packaging centers.

Support the development and completion of robust, risk-based, medical devices/combination products verification strategies.

- Analyze test data: design capability, regression analysis (trending), capability analysis (Cpk, k-value)
- Write, review, approve design verification plans, protocols and reports, support development of rationales justifying chosen approaches (eg acceptance criteria, statistical sampling, time points)
- Lead and track management of unexpected events (eg, discrepancies, complaints) for these medical devices/combination products within cGxP regulated area
- Facilitate planning and execution of early experimental testing (DoE)
- Support management during internal/external Quality inspections of Verification Engineering Labs and help define appropriate responses

REQUIREMENTS:

Technical/Engineering degree education, with additional statistical qualification (or equivalent experience). (Bachelor, Master or PhD in Engineering or Science discipline (pharmaceutical/biomedical/materials science, manufacturing or process control engineering or a related field)

Demonstrable practical knowledge of the following:

- Common Statistical Tools and Techniques (Descriptive Statistics, Hypothesis Testing)
- Measurement System Analysis
- Data trending
- Software for Statistics (eg Minitab)
- Root Cause Analysis
- Risk Assessment techniques
- Excellent command of spoken/written German and English
- Excellent documentation skills
- Process oriented and analytical thinking (educated in lean Six Sigma techniques highly desirable)
- Prior working experience in characterization of medical device/combination products, special/innovative packaging, or compact, complex, multi-material hand-held products is beneficial.
- Knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices is beneficial.

Want to experience Basel, gain international experience in one of the top cities in the world for quality of living and salaries, get in touch with our team of specialist.

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