Quality Engineer

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

Quality Engineer – Medical Device Industry

Job Summary

We are seeking a skilled Quality Engineer with 4–5 years of experience in the Medical Device industry to support quality assurance and compliance activities within a regulated manufacturing environment. The ideal candidate will have hands‑on experience with FDA regulations, ISO standards, CAPA, investigations, and quality system processes supporting medical device manufacturing and product development.

Key Responsibilities

• Support quality engineering activities for medical device manufacturing and product lifecycle processes
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements
• Lead and support investigations related to deviations, non-conformances, complaints, CAPA, and root cause analysis
• Perform risk assessments and support risk management activities in accordance with ISO 14971
• Review and approve quality documentation including SOPs, protocols, reports, work instructions, and engineering changes
• Support internal audits, supplier audits, and external regulatory inspections
• Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supplier Quality teams to resolve quality issues
• Participate in validation activities including IQ/OQ/PQ, process validation, and test method validation (TMV)
• Monitor manufacturing trends and quality metrics to identify continuous improvement opportunities
• Support change control activities and ensure proper documentation within the Quality Management System (QMS)
• Assist with supplier quality management and incoming quality processes
• Ensure compliance with Good Documentation Practices (GDP) and data integrity requirements

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field
• 4–5 years of Quality Engineering experience in the Medical Device industry
• Strong knowledge of:
  • FDA 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • CAPA and NCR processes
  • Root Cause Analysis methodologies
  • Experience working in GMP‑regulated manufacturing environments
  • Hands‑on experience with validation documentation and protocol execution
  • Strong understanding of Design Controls and Risk Management principles
  • Experience using QMS systems such as TrackWise, ETQ, Veeva, MasterControl, or similar
  • Excellent technical writing, communication, and problem‑solving skills
  • Ability to work independently and within cross‑functional teams