Sharon Higgins
Quality Manager at Auer Precision Company
- Role
- Medical Device Reprocessing Engineer at GE医疗
- Location
- Scottsdale, AZ, US
- LinkedIn followers
- 500 followers
OperationsView LinkedIn profile
Experience
Medical Device Reprocessing Engineer
Oct 2016 — Present · Phoenix, AZ, US
Working with new product development as well as legacy systems to develop cleaning, disinfection and sterilization processes for reusable medical devices.
Skills
- Dmaic
- Operational Excellence
- Quality Engineering
- Minitab
- Qc
- Gamp
- Medical Devices
- Capa
- Iso 9000
- Iso 13485
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- Change Control
- Pharmaceuticals
- Regulatory Requirements
- Design Control
- Fda Gmp
- Glp
- Validation
- Quality Control
- Cleaning Validation
- Gmp
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Continuous Improvement
- 21 Cfr
- Root Cause Analysis
- Six Sigma
- Gxp
- Quality Auditing
- Aseptic Processing
- 21 Cfr Part 11
- Quality Assurance
- Process Validation
- Sterilization
- Design of Experiments
- Regulatory Affairs
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