|Reference # : ||17-00640
||Title : ||Quality Engineer|
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||06/26/2017 / 09/22/2017
| Description |
Location: Irvine CA
Job Title: Quality Engineer
Start Date: June (3 month assignment)
Our customer is a medical equipment company specializing in artificial heart valves and hemodynamic monitoring.
Quality Engineer for a test method validation remediation project. This a long-term W-2 contract with a focus on process and equipment validations.
The Senior Quality Engineer will be required to:
• Lead test method development/validation activities, inclusive of verifying repeatability and reproducibility of methods.
• Write validation protocols based on information in process and equipment design documents as well as stakeholder input
• Write and execute protocols for Gage R&R and attribute test methods
• Ensure risk management and files are updated as necessary in relation to validations
• Analyze data and perform statistical analysis to ensure validation meets predefined acceptance criteria
• Must have BS degree in Engineering
• A minimum of 2 years of experience in Test Method Validation and Gage R&R within medical device or pharma industry
RCM is a recognized national leader in IT and regulatory compliance services providing a broad range of consulting and management services to pharmaceutical, biotech and medical device manufacturers. The unique combination of our IT, Regulatory, and Engineering Practices brings an unparalleled breadth of knowledge and experience to our clients.
RCM maintains a dedicated Life Sciences Practice that consistently reevaluates the market to determine areas of improvement. Our practice leaders constantly challenge ourselves to bring "true savings” whether through cost reduction or by reducing a products time to market.
We look forward to hearing from you!