Remote Senior Quality Engineer - FDA/ISO Compliance

Embecta Corp.; Parsippany-Troy Hills (NJ); Remote; USD 140,000 - 169,000; Full time

Job summary

Embecta Corp seeks a Senior Quality Engineer to ensure investigations, procedures, and activities comply with FDA QSR, ISO 13485, and Medical Device Directives for Vigilance. You will review customer complaint investigations for validity and ensure they are processed per corporate policies.

You will revise SOPs, enforce lab maintenance, conduct GLP-aligned analyses, perform FTIR testing, program lab equipment, and support internal and external audits.

Qualifications

• Regulatory and international standards requirements including 21 CFR 820, ISO 13485, ISO 14971.
• Statistics for trend analysis and complaint data evaluation.
• Quality Audit Management (internal and external) and CAPA investigations.

Responsibilities

• Ensure product complaint investigations comply with FDA QSR and ISO standards.
• Review investigations for validity and ensure compliance with policies.
• Revise SOPs and enforce maintenance, hazmat, and biohazard/disposal protocols.
• Support internal and external audits and prepare for lab tours.

Skills

FDA/Quality System Regulations

ISO 13485

CAPA

Root Cause Analysis

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Job description

Embecta Corp seeks a Senior Quality Engineer to ensure investigations, procedures, and activities comply with FDA QSR, ISO 13485, and Medical Device Directives for Vigilance. You will review customer complaint investigations for validity and ensure they are processed per corporate policies.

You will revise SOPs, enforce lab maintenance, conduct GLP-aligned analyses, perform FTIR testing, program lab equipment, and support internal and external audits.