Quality Engineer — Medical Devices (Remote/Hybrid)

Brasseler USA Inc.; Savannah (GA); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401K Plan with Company Match

Generous Time Off

Job summary

Brasseler USA Inc. is seeking a Quality Engineer to develop and implement systems ensuring products meet customer expectations and regulatory requirements.

You will participate in complaint handling, process validation, CAPA investigations, and supplier quality improvements to enhance product quality and patient safety. The role requires 3+ years in medical device engineering, a Bachelor's in engineering, and strong knowledge of LEAN/Six Sigma.

Qualifications

• 3+ years of engineering experience in medical devices.
• Experience in product development or manufacturing engineering.
• Strong knowledge of LEAN and Six Sigma practices.

Responsibilities

• Identify opportunities to improve product design and manufacturing processes.
• Provide quality engineering support across the product lifecycle, including risk management and CAPA investigations.
• Drive supplier quality improvements through analysis of component specs and root cause analysis.
• Collaborate with suppliers and manufacturing to reduce defects and improve yield.
• Ensure compliance with regulatory requirements and validation activities.

Skills

Quality engineering

Lean Six Sigma

Verbal & written communication

Project planning & management

Risk management

Education

Bachelor's degree in engineering

ASQ Certification

MBA or Master's degree (plus)

Tools

Statistical tools

CAPA methods

Job description

Brasseler USA Inc. is seeking a Quality Engineer to develop and implement systems ensuring products meet customer expectations and regulatory requirements.

You will participate in complaint handling, process validation, CAPA investigations, and supplier quality improvements to enhance product quality and patient safety. The role requires 3+ years in medical device engineering, a Bachelor's in engineering, and strong knowledge of LEAN/Six Sigma.