Remote Senior Quality Engineer – Medical Devices QA

Regulatory Jobs; New Jersey; Remote; USD 140,000 - 169,000; Full time

Benefits offered by this job

Telecommuting

Remote work opportunity

Job summary

embecta, a global medical device company, seeks a Senior Quality Engineer in Parsippany, NJ to ensure investigations, SOP updates, and regulatory compliance across the quality system. The role emphasizes GLP alignment, audit support, and LAB equipment management.

The position requires advanced engineering education with substantial experience in regulatory standards, quality engineering tools, and CAPA processes within medical device contexts.

Qualifications

• Master’s degree in Engineering or BA/BS with 5 years’ experience, per listing.
• Experience with 21 CFR 820, ISO 13485, ISO 14971 and QMS audits required.
• Proven skill in RCA, CAPA, DoE and data analysis for quality investigations.

Responsibilities

• Lead product complaint investigations and ensure regulatory compliance.
• Revise SOPs and ensure GMP/GLP adherence for the laboratory team.
• Support internal and external audits and CAPA activities.
• Program lab equipment (e.g., Chatillon) and perform FTIR analyses.

Skills

Regulatory knowledge

Statistical analysis

Root cause analysis

CAPA

Design of Experiments

DHF management

Quality audits

Engineering change management

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering with 5 years experience

Tools

FTIR analysis

Chatillon equipment

Job description

embecta, a global medical device company, seeks a Senior Quality Engineer in Parsippany, NJ to ensure investigations, SOP updates, and regulatory compliance across the quality system. The role emphasizes GLP alignment, audit support, and LAB equipment management.

The position requires advanced engineering education with substantial experience in regulatory standards, quality engineering tools, and CAPA processes within medical device contexts.