Senior Quality Engineer

Meet Life Sciences; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Meet Life Sciences is seeking a Medical Device Quality Engineer to support quality systems, regulatory compliance, and continuous improvement across the product lifecycle. This role collaborates with Engineering, Manufacturing, R&D, Regulatory, and Supply Chain to ensure products meet FDA and ISO13485 standards.

The candidate will lead CAPA, change control, risk management, and design controls, while developing documentation and participating in supplier quality activities.

Qualifications

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, or related field.
• 5+ years of quality engineering or manufacturing experience; medical device experience preferred.
• Knowledge of FDA and ISO 13485 quality requirements.
• Experience with CAPA, nonconformance, root-cause analysis, and risk management.
• Strong analytical, documentation, communication, and problem-solving skills.
• Experience with eQMS; ASQ certification is a plus.

Responsibilities

• Support compliance with FDA, ISO 13485, ISO 14971, and applicable quality standards.
• Investigate nonconformances, deviations, complaints, and quality issues using root-cause analysis.
• Lead or support CAPA, change control, risk management, and continuous improvement activities.
• Support design controls, process validation, equipment qualification, and product/process changes.
• Develop and maintain quality documentation, procedures, specifications, and records.
• Support supplier quality activities and internal/external audits.
• Analyze quality data and trends to identify opportunities for defect reduction and process improvement.
• Collaborate with cross-functional teams to resolve quality issues and improve product reliability.

Skills

Quality engineering

CAPA

Root-cause analysis

Risk management

Regulatory compliance

Education

Bachelor's degree in Engineering or related field

Tools

eQMS

Job description

I am working with an exciting small start-up Medical Device company who is looking to expand their team.

Medical Device Quality Engineer

Position Summary

The Medical Device Quality Engineer supports quality systems, regulatory compliance, and continuous improvement throughout the medical device product lifecycle. This role works closely with Engineering, Manufacturing, R&D, Regulatory, and Supply Chain teams to ensure products and processes meet quality and regulatory requirements.

Key Responsibilities

• Support compliance with FDA, ISO 13485, ISO 14971, and applicable quality standards.
• Investigate nonconformances, deviations, complaints, and quality issues using root-cause analysis.
• Lead or support CAPA, change control, risk management, and continuous improvement activities.
• Support design controls, process validation, equipment qualification, and product/process changes.
• Develop and maintain quality documentation, procedures, specifications, and records.
• Support supplier quality activities and internal/external audits.
• Analyze quality data and trends to identify opportunities for defect reduction and process improvement.
• Collaborate with cross-functional teams to resolve quality issues and improve product reliability.

Qualifications

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, or a related technical field.
• 5+ years of experience in quality engineering, manufacturing, or a related field; medical device experience preferred.
• Knowledge of FDA and ISO 13485 quality requirements.
• Experience with CAPA, nonconformance, root-cause analysis, and risk management.
• Strong analytical, documentation, communication, and problem-solving skills.
• Experience with eQMS, statistical methods, or ASQ certification is a plus.