Senior Quality Engineer - Remote Compliance & CAPA

Embecta Corp.; New Jersey; Remote; USD 140,000 - 169,000; Full time

Job summary

Embecta Corp. is seeking a Senior Quality Engineer to ensure FDA QSR, ISO 13485, and ISO 14971 compliance across product development and lifecycle. You will perform investigations, support CAPA and change control, and ensure DHF integrity while collaborating with cross-functional teams.

The role emphasizes statistical analysis, regulatory knowledge, and audit support, with a fully remote work arrangement and reporting to the Parsippany, NJ headquarters.

Qualifications

• Master’s in Engineering or Bachelor’s with 5+ years in quality engineering.
• Experience with FDA QSRs, ISO 13485, ISO 14971 is required.
• Strong statistical analysis and CAPA skills are essential.

Responsibilities

• Lead product complaint investigations and V&V activities.
• Maintain and improve quality system procedures and SOPs.
• Support internal and external audits and vendor qualification.

Skills

Regulatory compliance

Statistical analysis

Root cause analysis

Design of Experiments

CAPA

QMS audits

Engineering change

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Tools

DHF Management

21 CFR 820

Job description

Embecta Corp. is seeking a Senior Quality Engineer to ensure FDA QSR, ISO 13485, and ISO 14971 compliance across product development and lifecycle. You will perform investigations, support CAPA and change control, and ensure DHF integrity while collaborating with cross-functional teams.

The role emphasizes statistical analysis, regulatory knowledge, and audit support, with a fully remote work arrangement and reporting to the Parsippany, NJ headquarters.