| Quality Assurance Engineer Level II | St Paul, MN | 2010-07-06 |
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| Summary Overview: Provide Quality Engineering support to manufacturing and/or product development teams for biological and/or mechanical 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. •Support manufacturing on quality related process improvement projects, lean manufacturing projects, new equipment qualification. May be responsible for preparation/ review of protocols and reports, including the sampling, test methodology, data collection and statistical analysis. •Support product development teams to develop new products and transfer to manufacturing. Participate in risk management activities (quality planning, product and process risk assessment), process and product validation testing, component qualification, and test method development/validation. •Review nonconforming product reports (NCMR) 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, and perform supplier audits. •Participate on and lead process improvement teams to implement quality improvement activities. •Other duties, as assigned. Requirements: Minimum 4 year degree in engineering or related field of science, and 3-5 years of experience in Quality Assurance or Manufacturing. Experience in Medical Device Manufacturing is highly preferred. Mechanical engineering experience highly desireable. 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 required. DOE experience desireable. Must have working knowledge of MS Word, Excel, Outlook and Project applications. | ||
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TO APPLY FOR THIS JOB
Please choose one of the following options: |
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1. Fill out an online job application form
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3. Fax: 651.642.9018
Please include a fax cover sheet, Attention: Carol Norby and Karla Schiller |
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2. Submit your resume and cover letter
to Human Resources via e-mail: 
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4. Mail:
Synovis Surgical Innovations Attention: Carol Norby and Karla Schiller 2575 University Ave. W. St. Paul, MN 55114 |
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