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Advanced Quality Engineer – New Health Care Company
| Company | Solventum |
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| Location | San Antonio, TX, USA |
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| Salary | $95825 – $117120 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Mid Level |
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Requirements
- Bachelor’s Degree or higher in an Engineering field (completed and verified prior to start) from an accredited institution
- Three (3) years of experience as a Quality Engineer for a medical device or pharmaceutical company
- Three (3) years experience with United States Food and Drug Administration (FDA) regulations and recognized quality standards, including ISO14971 in a private, public, government or military environment.
Responsibilities
- Lead the development of process risk management per ISO14971 for assigned projects.
- Implements quality engineering services for new and existing medical device products to ensure compliance with the quality system for all projects.
- Supports failure investigations and problem resolution.
- Provide feedback to product development and manufacturing.
Preferred Qualifications
- Master’s degree in Biomedical Engineering, Manufacturing Engineering or Mechanical Engineering from an accredited institution
- Skills include project management, statistical analysis using Minitab, Power BI, conducting internal and external auditing, Six Sigma Green or Black Belt, Post Market and Complaint Trend Analysis, working with sterile barrier packaging, executing change management, participating in design reviews
- Quality conducting root cause investigations, reviewing and approving design history documentation, risk documentation, process validation reports, design verification/validation reports as well as performing statistical analysis such as process capability and determining sampling plans for incoming inspection, validation testing and design verification/validation.
