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| Company |
E-Technical Staffing, Inc. |
| Title: |
Quality Assurance Engineer |
| Category: |
Engineering / Industrial / Manufacturing |
| Description: |
| Summary Overview:
Provide Quality Engineering support to manufacturing and product development teams for biological devices to ensure proper development and execution of manufacturing processes. Identify manufacturing-related quality issues, implement quality improvement projects and participate in quality activities.
Other related activities include:
Provide support for released products, support the incoming inspection department and Quality Assurance lab where required, evaluate field returns, and develop corrective and preventative actions when necessary.
Specific duties include:
***Participate on product development teams to develop new products and transfer to manufacturing. Responsible for Quality planning, risk management, process validation, and Test Method development/validation.
***Support manufacturing on quality related process improvement or lean manufacturing projects.
***Review and approve changes (ECO***s, Deviations, etc.) to products and processes in production. ***Review nonconforming reports and disposition nonconforming material. ***Set inspection requirements, including identifying methods and sampling plans and designing inspection fixtures.
***Qualify suppliers; perform supplier audits and coordinate 1st article inspections. ***Participate on and lead process improvement teams to implement quality improvement activities. ***Other duties, as assigned.
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| Skills: |
Requirements:
Minimum 4 year degree in engineering or related field of science, and 3-5 years of experience in Quality or Manufacturing.
Experience in Medical Device Manufacturing is highly preferred.
Should have working knowledge of GMP and ISO 13485 requirements.
Must have excellent oral and written communication skills. Strong problem solving, technical writing and organizational skills.
Must have the ability to read/interpret design prints.
Knowledge of basic statistics and basic quality tools including SPC, Risk Analysis, Process Capability, DOE and others is required.
Must have working knowledge of MS Word, Excel, and Project applications. Microbiology and sterilization validation experience highly desirable.
Experience with biological products and/ or chemical processing highly desirable. |
| Employment type: |
Full Time |
| Salary: |
Unspecified |
| Degree: |
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| Experience: |
Unspecified |
| Location: |
St. Paul - Twin Cities - East Metro |
| Post Date: |
2008-12-30 |
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| Click here to Apply To this Job |
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