Senior Quality Engineer - Medical Devices (FDA/ISO)

Tecomet, Inc; West Palm Beach (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

Tecomet, Inc in West Palm Beach, FL is seeking a Sr. Quality Engineer to uphold FDA/ISO quality systems and drive continuous improvement. You will collaborate with manufacturing/operations to resolve quality, cost, and schedule issues, and lead CQE-focused activities such as FMEA, PPAP, and CAPA implementations.

Qualifications include a Bachelor's in Quality or related field, ASQ CQE/CMQ-QE preferred, and 4+ years in medical device quality. Knowledge of GMP, GDP, and Six Sigma is essential.

Qualifications

• Bachelor's Degree in Quality or related field.
• ASQ CQE or CMQ/QE certification preferred.
• 4 years' experience in quality within medical device manufacturing industry preferred.
• ISO 13485, FDA 820 and customer interaction experience preferred.

Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support the MRB and RMA processes.
• Work with team to solve quality, cost and schedule issues.
• Prepare FMEA's, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metric reports and cost of quality.
• Investigate customer complaints including CAPA, deviations, and complaint responses.
• Participate in audits and inspections.
• Write and maintain quality-related work instructions and procedures.
• Apply GMP and GDP and Six Sigma concepts.

Skills

Manufacturing operations

Measuring devices

Quality Systems

Regulations

Blueprint reading

GD&T

Metrology

Problem solving and 8D

Math skills

Microsoft Office

Minitab

Education

Bachelor's Degree in Quality or related field

ASQ CQE or CMQ/QE certification preferred

Job description

Tecomet, Inc in West Palm Beach, FL is seeking a Sr. Quality Engineer to uphold FDA/ISO quality systems and drive continuous improvement. You will collaborate with manufacturing/operations to resolve quality, cost, and schedule issues, and lead CQE-focused activities such as FMEA, PPAP, and CAPA implementations.

Qualifications include a Bachelor's in Quality or related field, ASQ CQE/CMQ-QE preferred, and 4+ years in medical device quality. Knowledge of GMP, GDP, and Six Sigma is essential.