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Quality Engineer/Validation Consultant
Eingestellt von Experis AG
Gesuchte Skills: Engineering, Engineer, Consultant
Projektbeschreibung
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.
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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Organisation/Management