Senior Quality Engineer - Medical Device GMP/ISO Leader

Exemplar Global; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Exemplar Global is seeking a Sr. Quality Engineer in Florida to ensure compliance with FDA, ISO 13485, GMP and GDP requirements. You will lead quality systems, CAPA, and deviation investigations, and drive process improvements across manufacturing and operations.

The role requires collaboration with MRB, suppliers, and customers, with emphasis on risk management, PPAP, FMEA, and statistical methods using Minitab and MS Office tools.

Qualifications

• Bachelor's degree in Quality or related field required or equivalent combination of education/experience.
• ISO 13485, FDA 820 familiarity is preferred.
• ASQ CQE or CMQ/QE certification is a plus.
• 4+ years of quality experience in medical device manufacturing preferred.

Responsibilities

• Maintain applicable quality systems, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Work with manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEAs, control plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metric reports (cost of quality, facts-based management).
• Investigate customer complaints including CAPA, deviations, and responses.
• Participate in audits and inspections.
• Write and maintain quality instructions and procedures.
• Demonstrate knowledge of GMP, GDP, FDA and ISO regulations.

Skills

Quality systems

CAPA

FMEA

PPAP

GMP

ISO 13485

GD&T

Metrology

Blueprint reading

8D

Minitab

MS Office

Education

Bachelor's Degree in Quality or related field

ASQ CQE or CMQ/QE preferred

Tools

Minitab

MS Office

Job description

Exemplar Global is seeking a Sr. Quality Engineer in Florida to ensure compliance with FDA, ISO 13485, GMP and GDP requirements. You will lead quality systems, CAPA, and deviation investigations, and drive process improvements across manufacturing and operations.

The role requires collaboration with MRB, suppliers, and customers, with emphasis on risk management, PPAP, FMEA, and statistical methods using Minitab and MS Office tools.