Quality Engineer
Exciting 6 Month development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care – is hiring a Quality Engineer to join their team!
As a Quality Engineer, you 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.
Pay: $30/hr.
Terms: 6 Month Contract
Key Duties:
- 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 nonconformance 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 OPs 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.
**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**