Quality Engineer

Tasks

• Support new product development and maintain quality deliverables in accordance with medical-device design control requirements.
• Develop, review, and approve design verification and validation protocols, reports, and supporting documentation.
• Develop and maintain product risk management documentation, including #DFMEA, #PFMEA, and risk assessments.
• Lead and support #CAPA, non-conformance, deviation, root cause analysis, and engineering change-control activities.

Requirements

• Minimum 5 years of quality engineering experience in the medical-device industry or a regulated life-sciences environment.
• Strong knowledge of #FDA Quality System requirements, #GMP, and #ISO 13485.
• Experience with #ISO 14971, design controls, and medical-device risk management.
• Hands-on experience with #CAPA, root cause analysis (#RCA), non-conformances, deviations, and change control.
• Preferred: Experience with design verification and validation, process validation, and equipment qualification.
• Preferred: Familiarity with #DFMEA, #PFMEA, #GD&T, and engineering change management.
• Preferred: Experience supporting audits, regulatory inspections, technical transfers, and continuous improvement projects.
• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical field.

How to apply

• Connect with us or send your resume by email.

Location

• Cincinnati, OH