Senior Quality Manufacturing Engineer - Hartland, WI
$101,000–$152,000 year
On-siteHartland, Wisconsin, United States
Job Summary
Manage the development and implementation of methods for process control, validation, and inspection to ensure products are ideal and functional. Design complex experiments to understand process variation, apply statistical process control methods for data analysis, and lead investigations of non-conformances to develop corrective and preventive actions. Generate and maintain device master records, design control files, and CE technical files while collaborating with suppliers on quality programs and 510K submissions. Requires a Bachelor's degree in Engineering or Science, at least 4 years of quality or engineering experience, and up to 15% travel.
Required Qualifications
- Bachelor's degree in Engineering, Science, Math or other related technical field
- At least 4 years of experience in the Quality or Engineering
- Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards)
- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation is necessary
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects
- Experience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations
- Experience leading a team to accomplish cross-functional goals
- Experience using MS Office Suite products(Word, Excel, PowerPoint, and Outlook)
- Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting)
- Position requires up to 15% travel
Desired Qualifications
- At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role
- Knowledge of advanced Six Sigma/Lean concepts
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