Remote-Eligible Medical Device Quality Engineer

henryschein; Savannah (GA); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Coverage

401K Plan with Company Match

Generous Time Off

Paid Parental Leave

Income Protection

Work Life Assistance Program

Flexible Spending Accounts

Educational Benefits

Worldwide Scholarship Program

Volunteer Opportunities

Job summary

Brasseler USA, a Henry Schein company, seeks a Quality Engineer to design and uphold robust quality systems ensuring products meet customer expectations and regulatory requirements including FDA, MDR/MDD. You will drive CAPA, risk management, design validation and process validation while collaborating with suppliers and manufacturing to reduce defects.

You will lead problem-solving efforts, analyze data, and push continuous improvement to maintain high product quality across the lifecycle.

Qualifications

• Bachelor's degree in engineering with a focus on quality.
• ASQ certification is a plus for progression.
• Experience in medical device quality and product development is preferred.

Responsibilities

• Develop and implement quality systems to meet customer and regulatory requirements.
• Lead CAPA investigations and risk management activities.
• Drive supplier quality improvements and analytics on process trends.
• Validate design inputs and perform verification/validation activities.
• Support regulatory compliance across multiple jurisdictions (FDA, MDR, MDD, MDSAP).

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA investigations

Supplier quality

Lean Six Sigma

Communication skills

Project management

Risk management

Statistical methods

Education

Bachelor's Degree in Engineering (Electrical/Mechanical)

ASQ Certification (optional)

Tools

Regulatory standards (FDA 21 CFR 820, MDR/MDD)

Quality systems (ISO 13485)

Job description

Brasseler USA, a Henry Schein company, seeks a Quality Engineer to design and uphold robust quality systems ensuring products meet customer expectations and regulatory requirements including FDA, MDR/MDD. You will drive CAPA, risk management, design validation and process validation while collaborating with suppliers and manufacturing to reduce defects.

You will lead problem-solving efforts, analyze data, and push continuous improvement to maintain high product quality across the lifecycle.