Medical Device Quality Engineer – Compliance & CAPA

Bihler of America Inc.; Phillipsburg (NJ); On-site; USD 85,000 - 125,000; Full time

Job summary

Bihler of America Inc. is seeking a Quality Engineer to support the quality management system across design, development, manufacture and distribution of medical devices.

You will manage document control, regulatory compliance, CAPA and risk management, coordinate sterilization activities, support validation, deliver training, and ensure audit readiness in cross-functional teams. This role requires a Bachelor’s degree in engineering and experience in ISO medical device environments with strong

Qualifications

• Bachelor’s degree in engineering or related field.
• Experience in ISO medical device environments.
• Proficiency with MS Excel and MS Word.

Responsibilities

• Maintain Quality Management System documentation and control.
• Ensure regulatory compliance (FDA 21 CFR 820, ISO 13485, ISO 14971).
• Lead CAPA investigations and effectiveness checks.
• Coordinate sterilization activities and validation support.
• Provide training and audit readiness support.

Skills

English communication

MS Excel

MS Word

Education

Bachelor’s degree in Engineering or related field

Tools

Electronic quality management system

Job description

Bihler of America Inc. is seeking a Quality Engineer to support the quality management system across design, development, manufacture and distribution of medical devices.

You will manage document control, regulatory compliance, CAPA and risk management, coordinate sterilization activities, support validation, deliver training, and ensure audit readiness in cross-functional teams. This role requires a Bachelor’s degree in engineering and experience in ISO medical device environments with strong