Senior Quality Engineer: Medical Device Quality & Compliance

Orchid Orthopedic Solutions LLC; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Orchid Orthopedic Solutions LLC in Florida is seeking a Senior Quality Engineer to ensure compliance with FDA, ISO and GMP standards while driving continuous improvement. You will interact with teams to resolve quality, cost and schedule issues and lead quality initiatives across manufacturing operations.

The role requires a strong background in quality systems, FMEA/PPAP, and problem-solving methods, with experience in medical device manufacturing and regulatory requirements.

Qualifications

• Bachelor's degree in quality or related field with acceptable experience.
• ASQ CQE or CMQ/QE preferred but not mandatory.
• 4 years' quality experience in medical device manufacturing preferred.
• ISO 13485, FDA 820 knowledge and customer interaction experience preferred.

Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Collaborate with manufacturing/ops to resolve 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; cost of quality, management by facts.
• Investigate customer complaints including CAPA, deviations, and responses.
• Participate in audits and inspections.
• Write and maintain quality related work instructions and procedures.

Skills

Quality systems

Regulations FDA GMP ISO

Blueprint reading

GD&T

Metrology

8D problem solving

Math skills

MS Office

Minitab

Measuring devices

Manufacturing operations

Education

Bachelor's Degree in Quality or related field

ASQ CQE or CMQ/QE preferred

Tools

Minitab

Microsoft Office

Calipers

Job description

Orchid Orthopedic Solutions LLC in Florida is seeking a Senior Quality Engineer to ensure compliance with FDA, ISO and GMP standards while driving continuous improvement. You will interact with teams to resolve quality, cost and schedule issues and lead quality initiatives across manufacturing operations.

The role requires a strong background in quality systems, FMEA/PPAP, and problem-solving methods, with experience in medical device manufacturing and regulatory requirements.