Quality Engineer, Medical Devices & QMS Auditor

VISIONQUEST INDUSTRIES INC; Vista (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

VQ OrthoCare is seeking a Quality Engineer to support product and process quality through investigation, analysis, auditing and cross-functional quality activities. The role focuses on applying ISO 13485 and FDA requirements and driving continual improvement.

You will investigate defects, collect and analyze data, and lead corrective actions within a collaborative environment across Quality, Manufacturing and Product Development. Onsite in Vista, CA; full-time role.

Qualifications

• Five to seven years of progressive quality experience in a regulated environment.
• Knowledge of ISO 13485 and FDA medical device quality requirements.
• Experience with audits, investigations and corrective action.

Responsibilities

• Apply Quality System principles per ISO 13485 and FDA requirements.
• Serve as internal QMS auditor and plan/perform audits.
• Investigate defects, evaluate data and identify root causes.
• Lead corrective action and quality improvement activities.
• Develop and maintain documentation and device master records.

Skills

ISO 13485

FDA medical device

QMS Audits

Root-cause analysis

Data analysis

Corrective action

Cross-functional collaboration

Job description

VQ OrthoCare is seeking a Quality Engineer to support product and process quality through investigation, analysis, auditing and cross-functional quality activities. The role focuses on applying ISO 13485 and FDA requirements and driving continual improvement.

You will investigate defects, collect and analyze data, and lead corrective actions within a collaborative environment across Quality, Manufacturing and Product Development. Onsite in Vista, CA; full-time role.