Quality Engineer

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.

• 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

• 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 Track Wise, ETQ, Veeva, Master Control, or similar
  • Excellent technical writing, communication, and problem‑solving skills
  • Ability to work independently and within cross‑functional teams