Medical Device Quality Engineer: CAPA, ISO 13485 Expert

Novozen Healthcare LLC; Delaware; On-site; USD 75,000 - 95,000; Full time

Job summary

Novozen Healthcare LLC is looking for a skilled Quality Engineer to join their team in Delaware. This role requires 4–5 years of experience in the Medical Device industry, with expertise in FDA regulations and ISO standards.

The ideal candidate will support quality assurance processes, lead investigations, and ensure compliance with regulatory requirements, all within a dynamic team environment focused on innovation and quality improvement.

Qualifications

• 4–5 years of Quality Engineering experience in the Medical Device industry.
• Excellent technical writing and communication skills.
• Ability to work independently and within cross-functional teams.

Responsibilities

• Support quality engineering activities for medical device manufacturing.
• Ensure compliance with FDA and ISO regulatory requirements.
• Lead investigations related to deviations and non-conformances.
• Perform risk assessments in accordance with ISO 14971.

Skills

FDA 21 CFR Part 820

ISO 13485

ISO 14971

CAPA and NCR processes

Root Cause Analysis methodologies

Validation documentation

GMP-regulated manufacturing experience

Technical writing

Communication skills

Problem-solving

Education

Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field

Tools

QMS systems such as TrackWise, ETQ, Veeva, MasterControl

Job description

Novozen Healthcare LLC is looking for a skilled Quality Engineer to join their team in Delaware. This role requires 4–5 years of experience in the Medical Device industry, with expertise in FDA regulations and ISO standards.

The ideal candidate will support quality assurance processes, lead investigations, and ensure compliance with regulatory requirements, all within a dynamic team environment focused on innovation and quality improvement.