ISO 13485 Quality & Validation Engineer — Medical Devices

Sterling Engineering; Chicago (IL); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Sterling Engineering is seeking a hands-on Quality Engineer to support manufacturing validation and quality process development in a regulated environment. The role focuses on IQ/OQ/PQ validations, in-process controls, and batch release procedures to ensure readiness for production.

The ideal candidate will build validation systems from the ground up, assess risks, and collaborate with Manufacturing, Engineering, and Product Development teams to deliver reliable quality systems and improved

Qualifikationen

• Experience working within an ISO 13485 quality management system is required.
• Strong hands-on experience with IQ/OQ/PQ process validation.
• Experience in regulated medical device manufacturing.
• Understanding of process controls, risk assessments, and product quality.
• Ability to develop validation processes and quality systems from the ground up.
• Strong problem-solving skills and ability to work primarily onsite.

Aufgaben

• Develop and execute IQ/OQ/PQ manufacturing process validations.
• Establish in-process quality controls, inspection checkpoints, and batch release procedures.
• Assess process risks and evaluate the impact of manufacturing defects on product quality.
• Collaborate with Manufacturing, Engineering, and Product Development teams.
• Develop validation protocols, documentation, and quality procedures.
• Support manual and semi-automated manufacturing processes and new production launches.

Kenntnisse

IQ/OQ/PQ validation

Regulatory knowledge

Problem solving

Cross-functional collaboration

Tools

ISO 13485

Jobbeschreibung

Sterling Engineering is seeking a hands-on Quality Engineer to support manufacturing validation and quality process development in a regulated environment. The role focuses on IQ/OQ/PQ validations, in-process controls, and batch release procedures to ensure readiness for production.

The ideal candidate will build validation systems from the ground up, assess risks, and collaborate with Manufacturing, Engineering, and Product Development teams to deliver reliable quality systems and improved