MedTech Quality Engineer — CAPA, Validation & Compliance

BD; El Paso (TX); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

BD is a leading medical technology company seeking a Quality Engineer to support manufacturing processes and ensure quality system compliance. The role involves leading CAPA investigations, data analysis, and collaboration with cross-functional teams.

Responsibilities include maintaining FDA/ISO compliance, validating processes, and supporting audits and regulatory inspections. Strong writing, communication, and problem-solving skills are essential, with bilingual English/Spanish preferred.

Qualifikationen

• Bachelor’s degree in Engineering is required; Master’s preferred.
• Minimum 4 years of Engineering/Quality Engineering experience in medical devices/pharma or equivalent with a Bachelor’s degree.
• Minimum 2 years of Engineering/Quality Engineering experience with a Master’s degree in a regulated environment.
• Fluent English communication skills; bilingual in English/Spanish preferred.

Aufgaben

• Provide quality engineering support for manufacturing processes to ensure FDA/ISO/GMP compliance.
• Lead investigations for nonconformances, deviations, complaints, and CAPA with root cause and corrective actions.
• Analyze quality metrics and data to identify trends and drive continuous improvement.
• Develop, review, and approve quality documentation and validation activities.
• Support regulatory submissions, audits, and regulatory inspections.

Kenntnisse

CAPA

Root Cause

Process Validation

Statistical Analysis

Lean Manufacturing

FDA Regulations

ISO 13485

Audit Readiness

Change Control

Cross-functional

English Proficiency

Bilingual

CQE Certification

Project Management

Technical Writing

Ausbildung

Bachelor's degree in Engineering

Master’s degree in Engineering Preferred

Jobbeschreibung

BD is a leading medical technology company seeking a Quality Engineer to support manufacturing processes and ensure quality system compliance. The role involves leading CAPA investigations, data analysis, and collaboration with cross-functional teams.

Responsibilities include maintaining FDA/ISO compliance, validating processes, and supporting audits and regulatory inspections. Strong writing, communication, and problem-solving skills are essential, with bilingual English/Spanish preferred.