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Company | Intellectt Inc |
Address | Temecula, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Staffing and Recruiting |
Expires | 2023-12-16 |
Posted at | 10 months ago |
Hello, Hope you are doing well. Please share your updated resume to [email protected]
- Track nonconforming material and lead Material Review Board (MRB) efforts.
- Lead complaint investigations on returned products.
- Establish, monitor and evaluate quality system metrics.
- Manage corrective action and quality improvement activities.
- Provide in-process QA support to include inspection and document review.
- Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
- Develop incoming inspection processes and document incoming inspection activities.
- Complete final acceptance activities.
- Manage the sterilization process, including validations and product sterile loads.
- Manage aspects of the internal quality system relating to receiving inspection, calibration, MRB, etc.
- Support quarterly management review meetings.
- Assist in the performance of quality system internal auditing.
- The requirement is that the Quality Engineers at this site do need an engineering degree.
- Manufacturing line support
- 3-5 years in any of the following:
- Medical (or other highly regulated industry) Audit support experience Medical device complaint investigations
- This is for an engineering position that will have a heavy emphasis on adherence to medical device regulations that require a lot of writing and supporting areas of the manufacturing ancillary areas, such as warehouse, e-beam, chemical mixing & Laboratories.
- Exhibit Excellent teamwork ability to work with cross functional team across the world including upper management
- Excellent communication and investigating writing skills (CAPA)
- Strong background with engineering fundamentals
- Understanding of or willingness to learn and work within highly regulated industry
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