SysMind Tech
Location: Shelton,CT, USA
Date: 2024-11-22T09:11:28Z
Job Description:
- Experience in supporting medical device manufacturing.
- Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
- Validation Experience, especially cleaning
- Processes experience, molding, cleaning, packaging
- Specific experience with Test method Validation and Gage R&R
- Experience with root cause analysis and problem-solving for both technical and process issues
- Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003
- Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
- Good problem-solving skills through the use of quality and statistical tools, Six Sigma
- Ability to read and understand engineering drawings.
- Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
- Knowledge of Quality System requirements, ISO and FDA requirements
- Ability to effectively work within a cross-functional team to complete critical project tasks.
- Demonstrates good written and verbal communication skills.
- Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions and proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts.
- Microsoft Office Suite and Project