Quality Engineer I
Mountain Home, AR
Req ID 51087BR
Business Title
Quality Engineer I
Business
Global Quality
Sub-Business
Medical Products Support
Country
US
State/Province
Arkansas
Location of Position
Mountain Home, AR
Shift_
1st
Job Description
This position assists in developing and implementing new machines/processes and in improvements to existing methods. Requirements for new/improved machines/processes, including system specification, risk assessment/analysis, installation qualification, operational qualifications, and performance qualification
•Supports the manufacturing plant through implementation of process improvements.
•Responsible for risk assessment evaluations/mitigations for assembly and process of applicable Mountain Home products.
•Evaluates sampling plans with respect to current quality levels and test vides statistical assistance to Quality Management and Production.
•Accountable for project timelines as established by local project team of mfg,quality and engineering.
•Composes protocols, final reports, studies, experiments, and general information reports.
•Participates in team validation efforts of new equipment and changes to existing equipment.
•Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP's, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Corporate Quality Manual (CQM), ISO 13485-2003, Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC and other applicable standards and regulations.
•Basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
Job Requirements
•Strong technical writing skills
•Basic statistical analysis knowledge.
•Good interpersonal communication skills.
•Self motivated, detail oriented and task driven
•Skilled in Microsoft Excel, Word, Powerpoint or equivalents. Skilled in Infinity QS, MiniTab/StatGraphics or equivalents.
•Ability to discuss normally encountered technical or project management issues, both verbally and in written form.
•Ability to work as a collaborative team member.
•Ability to solve routine design, engineering problems with assistance.
•B.S. and 0 - 1 year related experience (in-house, co-op or acquired outside).
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
