Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Documentation, Engineering, ISO (International Organization for Standardization), Injection Molding, Manufacturing, Medical Equipment, Performance Management, Plastics Manufacturing, Problem Solving Skills, Process Improvement, Process Manufacturing, Quality Engineering, Quality Management, Quality System Requirements (QSR), Root Cause Analysis, Trend Analysis, Validation Documentation
Oxford Solutions currently has a direct hire opening for aManufacturing Quality Engineer. This position is onsite and is best suited for a hands-on quality engineering professional with strong experience in injection molding, CAPA, ISO 13485, and customer-facing quality support.
The Manufacturing Quality Engineer will support quality systems, production quality, corrective actions, and customer quality requirements in a regulated manufacturing environment.
Responsibilities
- Develop, maintain, and improve quality processes within a manufacturing and injection molding environment.
- Support ISO 13485 quality system requirements, audits, documentation, and compliance activities.
- Lead and support CAPA investigations, root cause analysis, corrective actions, and preventive actions.
- Work closely with production, engineering, and operations teams to resolve quality issues and improve process performance.
- Serve as a customer-facing quality contact for issue resolution, quality updates, and corrective action responses.
- Review quality data, identify trends, and recommend process improvements.
- Support inspection methods, quality documentation, validation activities, and continuous improvement initiatives.
Requirements
- College degree preferred; will consider 4+ years of quality engineering experience in lieu of degree.
- 3+ years of quality engineering experience in a manufacturing environment, including injection molding experience.
- Experience with ISO 13485 quality systems.
- CAPA experience, including root cause analysis, corrective action, and preventive action processes.
- Customer-facing quality experience, including communication with customers on quality issues or corrective action responses.
- Strong documentation, problem-solving, and cross-functional communication skills.
- Ability to work onsite in a hands-on manufacturing setting.
Preferred Background
- Experience in medical device, plastics, precision manufacturing, or other regulated manufacturing environments.
- Knowledge of quality tools, audits, validation, nonconformance management, and continuous improvement methods.
Manufacturing Quality Engineer – Injection Molding - 26-00510
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