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Quality Engineer (Medical/Pharma)
USD40 - USD50 per hour (USD83,194 - USD103,992)
Full Time, Contract Opportunity
Quality Engineering (Medical/Pharma)
About Our Client
A national medical and pharma organization.
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.
- Establishes statistical reliability by using mean time before failure, reliability modeling, and reliability demonstration tests.
- Develop or assist in development of process FMEAs, risk assessments, control plans for critical process parameters and quality attributes
- Develops experiments by applying full and fractional factorial techniques.
- Develops sampling plans by applying attribute, variable, and sequential sampling methods.
- Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
- Prepares reports by collecting, analyzing, and summarizing data; making recommendations.
- Author cleaning validation protocol and report, including supporting calculation of the maximum allowable carryover (MAC), rinse/swab limits, etc.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining American society of quality control certified quality engineer qualification.
- Software packages such as project management, spreadsheets, word processors and packages unique to the individual's specialty(s) area.
The Successful Applicant
- Minimum 5 years of experience in technical/quality Engineering field, B.S. required
- Minimum 3-5 years' experience in Pharma and Medical Quality Engineering
- Advanced MS Office skills, MS Project Software
- Ability to multi-task between projects
- Demonstrate good analytical and problem solving skills
- Ability to work under minimal supervision, with management guidance
- Familiarity with rules, regulations, best practices and performance standards
- Excellent written and verbal communication skills
What's on Offer
Dependent upon experience.