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New Product Introduction - Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
3 weeks ago
- Risk Management
- GD&T
- PFMEA
3 weeks ago
Our client is seeking an experienced Quality Engineer to support New Product Introduction (NPI) and manufacturing activities within a regulated manufacturing environment.
This individual will work closely with Manufacturing, Engineering, and Operations to ensure products and processes meet quality and customer requirements.
Responsibilities:
- Developing and maintaining inspection plans, reviewing and interpreting engineering drawings and specifications, creating and executing quality protocols, and supporting IQ/OQ/PQ activities.
- The Quality Engineer will also be responsible for measurement system analysis (MSA), Gage R&R studies, inspection methods, control plans/control blocks, and ensuring appropriate measurement and inspection techniques are established for new and existing processes.
- The Quality Engineer will play an active role in process risk management and continuous improvement, including development and review of PFMEAs, control plans, process documentation, and inspection plans.
- The role will involve partnering with Manufacturing and Engineering to translate drawings and product requirements into effective inspection and manufacturing controls, identifying potential quality risks, and supporting root cause analysis and corrective actions.
- Experience working within an NPI environment, interpreting GD&T and engineering drawings, developing inspection protocols, and implementing quality controls on the manufacturing floor is highly preferred.
- Strong knowledge of statistical quality tools, MSA/Gage R&R, PFMEA, IQ/OQ/PQ, and general manufacturing quality processes is required.
New Product Introduction - Quality Engineer · Katalyst Healthcares & Life Sciences