AL
Quality Engineer I
Artech LLC
🇺🇸 United States
On-site
11 months ago
- triage
11 months ago
Not enough detail in this posting to match
Location: Johns Creek GA
Duration: 24+ Months
Pay Range: $30/hr - $34/hr
- The Associate QA Engineer will lead activities involving product impact assessments, product quarantine, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation to 21CFR820, ISO and internal requirements.
- Actively participates in Production Triage team as the lead Quality member by providing direction and support to the non-conformance process, product quarantine as non-conformance arise.
- Ensure non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.
- Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/dispositioning non-conformance records for quarantine release and removal of product from quarantine area.
- Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.).
- Analyze audit results for trends and provide feedback to QA OP’s Management and QA team.
- Initiates and leads QA Operations process improvement projects from developing the business case through to implementation including creating/revising procedures using the Change Control process.
- Conducts failure investigation to analyze internal system or process failures and implement preventive and corrective action. Uses various statistical and non-statistical problem-solving tools as part of analysis.
- Bachelor’s degree in Engineering Required
Quality Engineer I · Artech LLC