Medical Device Quality Engineer: Impactful & Regulated

Brasseler USA Inc.; Savannah (GA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K Plan with Company Match

Paid Parental Leave

Time Off & Holidays

Educational Benefits

Job summary

Brasseler USA Inc. is seeking a seasoned Quality Engineer to design and implement systems ensuring products and services meet customer expectations and regulatory requirements. The role covers complaint handling, process validation, nonconformities, product development and supplier quality to support verification, validation and problem solving.

Minimum 3+ years in medical device quality engineering with LEAN/Six Sigma experience. Bachelor's in engineering preferred; ASQ certification a plus.

Qualifications

• Experience in quality engineering within medical devices and manufacturing.
• Knowledge of 21 CFR 820, MDD/MDR, ISO 14971 and ISO 60601.
• Lean Six Sigma and CAPA methodologies (risk-based thinking).

Responsibilities

• Engage in continuous improvement to reduce defects in design and manufacturing.
• Provide quality engineering support across product lifecycle including risk management.
• Lead supplier quality improvements and perform root cause analysis.
• Partner with suppliers and manufacturing to improve yield and reduce defects.
• Conduct trend analysis and drive corrective/preventive actions (CAPA).
• Validate designs inputs and ensure product and process quality per standards.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA investigations

Supplier quality

Process validation

Risk management

LEAN/Six Sigma

Communication skills

Education

Bachelor's degree in engineering

ASQ Certification (plus)

Job description

Brasseler USA Inc. is seeking a seasoned Quality Engineer to design and implement systems ensuring products and services meet customer expectations and regulatory requirements. The role covers complaint handling, process validation, nonconformities, product development and supplier quality to support verification, validation and problem solving.

Minimum 3+ years in medical device quality engineering with LEAN/Six Sigma experience. Bachelor's in engineering preferred; ASQ certification a plus.