Quality Engineer, Medical Devices | CAPA & Validation

RXinsider LTD.; El Paso (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

BD in Texas seeks an experienced Quality Engineer to support manufacturing processes and ensure compliance with FDA regulations, ISO standards, and GMP requirements. You will drive quality initiatives across the product lifecycle.

You will lead investigations of nonconformances and customer issues, perform CAPA, validate processes, and collaborate with cross-functional teams to improve quality metrics while maintaining robust documentation and readiness for audits.

Qualifications

• Bachelor’s degree in Engineering required; Master’s preferred.
• 4+ years in engineering/quality engineering in medical devices or regulated pharma with a bachelor.
• Experience with FDA QSR (21 CFR 820) and ISO 13485.
• Strong root cause analysis and CAPA skills.
• English communication skills; bilingual English/Spanish preferred.

Responsibilities

• Provide quality engineering support for manufacturing processes to ensure FDA/ISO/GMP compliance.
• Lead investigations of nonconformances, deviations, customer complaints, OOS results, audit findings and CAPA.
• Evaluate manufacturing processes and data to identify trends and drive continuous improvement.
• Develop, review and approve quality documentation and validation records.
• Support IQ/OQ/PQ, cleaning validation, software validation and test method validation.
• Participate in change control by assessing QA/regulatory impact of proposed changes.
• Utilize quality tools: statistical analysis, FMEA, risk management.
• Analyze quality metrics and collaborate with multiple departments to improve product quality.
• Support internal, supplier and regulatory audits and implement corrective actions.
• Promote a culture of quality, compliance and continuous improvement.
• Ensure safety, environmental, and company policies compliance.

Skills

FDA QSR 21 CFR 820

CAPA investigations

Process validation

Statistical analysis

Risk management

Documentation

English proficiency

Bilingual EN/ES (preferred)

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering preferred

Tools

CQE certification (ASQ)

Job description

BD in Texas seeks an experienced Quality Engineer to support manufacturing processes and ensure compliance with FDA regulations, ISO standards, and GMP requirements. You will drive quality initiatives across the product lifecycle.

You will lead investigations of nonconformances and customer issues, perform CAPA, validate processes, and collaborate with cross-functional teams to improve quality metrics while maintaining robust documentation and readiness for audits.