Beschreibung
Senior Quality Engineer/Validation Consultant
Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.
For one of our client, specialized in the medical devices area based Neuchatel, we are looking for a Senior Quality Engineer and Validation Consultant.
This is a challenging, contracting position, starting in July until the end of 2019.
Responsibilities:
- Support and lead design control activities
- Champion supplier risk management activities
- Establish and review protocols, reports, procedures, specifications and systems to provide QSR/ISO compliance consistent with the development of medical device products
- Conduct and lead process validation activities
- Conduct and lead process/design failure mode effects and analysis
- Develop inspection methodology and acceptance criteria for inspection sample plans
- Apply statistical methods to evaluate test data and processes.
- Perform test method validation and Gage R&R studies for new inspection techniques and test equipment
- Conduct internal audits of the quality system to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements
- Perform product/process specific supplier assessments
- Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Nonconforming Materials, Risk Management, etc.
- Provides leadership in the understanding of medical device regulations to other disciplines.
- Support Base Business and Production Improvement Initiatives
You bring to this role:
- BS degree in an engineering or technical discipline
- Knowledge and application of FDA QSR, ISO 13485:2003, and ISO 14971:2007 is
- Strong quality engineering skills with a proven track record in design verification/validation process verification/validation, and design/process failure modes and effects analyses
- Experience with Blueprint literacy including GD&T
- Previous experience in a medical device or a healthcare company
- Proven track record experience in implementing Quality System improvements to meet compliance and overall business goals
- Proficiency with the Microsoft Office Suite is preferred
- Knowledge of MiniTab is a plus
- Strong communication skills with fluently in English and French
Start Date: 02.07.2018
Location: Neuchatel
If you've any further questions on the role please call Julie Mackerer.