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