Search Jobs: Results: Senior Advanced Quality Engineer
PLEASE DO NOT APPLY IF YOU DON'T HAVE MEDICAL DEVICE OR PHARMACEUTICAL PRODUCT DEVELOPMENT EXPERIENCE.
The company is moving forward on a number implantible product areas. This is a global leasder in the field of medical devices and has excellent benefits.
The position of the Sr. Advanced Quality Engineer is responsible to assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. This individual will represent quality interests and concerns on project teams and report to the Manager of Advanced Quality Engineering.
Responsibilities:
Qualifications:
• Bachelor Degree in Engineering or Technical Sciences or equivalent work experience.
• 5 years minimum experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.
• A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
• Strong Design Control understanding from concept to launch
• Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001
• Relevant experience with one or more of the following device technologies:
- Resorbable Polymers
- Active Pharmaceutical Ingredients- Combination
Devices
- Polymer Coating Processes
• 5 years minimum experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.
• A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
• Strong Design Control understanding from concept to launch
• Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001
• Relevant experience with one or more of the following device technologies:
- Resorbable Polymers
- Active Pharmaceutical Ingredients- Combination
Devices
- Polymer Coating Processes
Job Details
| Name: | David Griffith | Date Posted: | 7/21/2010 |
| Office: | Charlotte | Telephone: | (704) 889-1100 |
| Email: | dgriffith@fpccharlotte.com | Fax: | |
| Category: | Medical Device | ||
| Keywords: | quality engineer, design control ,fmea,product validation, process validation,doe,spc, rgression analysis,iso 9001,iso 13485,fda combination products, resorbable polymers, polymer coating, drug eluting stents, | Region: | New England (MA, ME, NH, RI, VT) |
| State: | City: | ||
| Education: | BS | Job Number: | J43842-CLTT-DBG-981 |
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