Quality Engineer I - Medical Devices | FMEA & CAPA

Orchid Orthopedic Solutions LLC; Claypool (IN); Sur place; USD 60 000 - 80 000; Plein temps

Résumé du poste

Orchid Orthopedic Solutions LLC in Indiana seeks a Quality Engineer I to ensure compliance with FDA, ISO, GMP and GDP standards while supporting continuous improvement and customer-driven quality.

You will work with manufacturing to solve quality, cost and schedule issues; prepare FMEA, control plans, PPAP; coordinate validations; and investigate complaints with CAPA and deviations.

Bachelor’s degree in engineering or 4+ years in medical device quality; ASQ CQE/CMQ/QE preferred.

Qualifications

• Bachelor’s degree in engineering or related field, or 4+ years in medical device quality
• ASQ CQE or CMQ/QE certification preferred
• 2+ years of quality experience in medical device manufacturing preferred
• ISO 13485, FDA 820 familiarity and customer interaction preferred

Responsabilités

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEAs, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generating applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
• Special projects as assigned by quality management.
• Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
• Standard problem-solving techniques.
• Applies statistical and Six Sigma concepts and techniques.
• Works with Internal and External Customers.
• Participates in audits and inspections.

Connaissances

Measuring devices

Quality Systems

Regulations

Blueprint reading

GD&T

Metrology

8D problem solving

Math skills

Microsoft Office

Minitab

Formation

Bachelor's Degree in Engineering or related field

ASQ CQE or CMQ/QE

Description du poste

Orchid Orthopedic Solutions LLC in Indiana seeks a Quality Engineer I to ensure compliance with FDA, ISO, GMP and GDP standards while supporting continuous improvement and customer-driven quality.

You will work with manufacturing to solve quality, cost and schedule issues; prepare FMEA, control plans, PPAP; coordinate validations; and investigate complaints with CAPA and deviations.

Bachelor’s degree in engineering or 4+ years in medical device quality; ASQ CQE/CMQ/QE preferred.