HireDiversity

Neuchâtel, CH

Quality Engineer - CDI-000009O6

Description

The Quality Engineer role provides quality engineering support for base business, new product development, and supplier quality. Products include Women's Health and Urology devices and absorbable hemostats.

He/She will partner with Operations, R&D, Engineering, and other departments to ensure products are efficiently and effectively transferred and integrated into base-business manufacturing.

Responsibilities

GENERAL
- Function as a project team member in matters relating to Quality Engineering
- Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, design of experiments, statistical data analysis, statistical process control, measurement system analysis and development of sample plans troughout the product lifecycle
- Ensure the development of a comprehensive risk management plan for the product and process
- Ensure effective quality strategies for validation
- Ensure the development and validation of appropriate test methods for product and process performance
- Ensure effective and consistent application of Quality Engineering and PE tools and techniques, including but not limited to Design of Experiments, capability analysis, control charing, pFMEA, CTQ flow down, and root cause analysis
- Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action
- Effectively utilize Process Excellence to solve problems and develop optimal products and processes
- Provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as medical device regulations
- Additional ad-hoc roles may be assigned as required

NEW PRODUCT DEVELOPMENT SUPPORT
- Partner with R&D to ensure the application of design controls and product risk management
- Partner with R&D in the investigation/correction of design failures/challenges
- Ensure effective design control and transfer
- Partner with R&D in the development and conduct of the physical challenges associated with product performance
- Assist R&D with new test method development and validation
- Proactively communicate with QE'S product CTQs for process development/validation/control

EXTERNAL SUPPLIERS OF RAW MATERIAL AND FINISHED GOODS SUPPORT
- Partner with Engineering and Suppliers to ensure the application of process validation, process control, and process risk management
- Partner with Engineering and Suppliers in the investigation/correction of process failures
- Implement and monitor process capability for continuous improvement
- Ensure effective change control
- Proactively communicate any changes in design or changes in process that could affect product design
- Develop systems to ensure quality of purchased raw materials and finished goods
- Ensure supplier performance is monitored and addressed as needed. Provide leading metrics to QA/RA Business Unit Directors
- Utilize technical skills specific to assigned commodities (ex., sterilization, plastics, chemicals, etc.) to ensure adequate quality plans

FOR ETHICON SITES SUPPORT
- Partner with Operations Engineering in the application of process validation, process control, and process risk management
- Partner with Operations in the investigation/correction of process failures
- Implement and monitor process capability for continuous improvement
- Ensure effective change control
- Proactively communicate any changes in design or changes in process that could affect product design

Qualifications

- At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science
- Minimum 4 years related experience in a regulated industry such as Pharmaceuticals, Biologic or Medical Device manufacturing
- Certified Quality Engineer (ASQ or equivalent) preferred
- Equipment and process validation experience required
- Automation experience is preferred
- Packaging process experience is preferred
- Green Belt or Black Belt certification from a recognized program
- Thorough working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, sampling statistics and techniques, CTQ flow down, pfMEA, root cause analysis
- Demonstrated knowledge and application of cGMPs, QSR, MDD, ISO9000, 9001, 9002, 13485, 14971 and other international standards
- Knowledge of GAMP recommendations
- Geometric Dimensioning and Tolerancing
- Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project)
- Fluent in English (oral and written)
- Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and project documentation
- Effective technical writing
- Sense of urgency, intellectual curiosity, prudent risk-taking
- Able to travel up to 15%

Primary Location:Europe/Middle East/Africa-Switzerland-Neuchâtel-Neuchâtel
Organization: Ethicon SarL (8786)
Job Function: Quality (Eng)