Quality Engineer II - Medical Devices & Process Excellence

Orchid Orthopedic Solutions Alabama; Memphis (TN); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Performance bonuses

Job summary

Orchid Orthopedic Solutions Alabama seeks a Quality Engineer II to support the quality of legacy medical devices and collaborate with project management and manufacturing engineers on new production introductions and ongoing validation.

The role uses statistical methods, quality tools, and APQP deliverables to ensure product quality, CAPA effectiveness, and supplier quality support, with opportunities for training and growth.

Qualifications

• Bachelor of Science or equivalent required.
• B.S. preferred for advanced roles.

Responsibilities

• Completes all required training and adheres to quality standards.
• Applies quality tools (Pareto, SPC, regression analysis) to drive improvements.
• Processes customer quality complaints and supports CAPA activities.
• Collects, analyzes, and presents data using statistical methods.
• Supports QA by assisting suppliers with quality requirements.
• Participates in APQP deliverables including risk analysis and PFMEA.
• Plans and conducts IQ/OQ/PQ validations for equipment and processes.
• Interacts with customer contacts to clarify requirements.
• Determines process capability and develops inspection criteria with sampling plans.
• Leads productivity and continuous improvement projects.
• Watches for safety and ensures compliance with QMS procedures.

Skills

Quality management

Process management

Operations experience

Communication

Attention to detail

Manufacturing safety

Lean manufacturing

Statistical analysis

PPAP

Production runs

Final inspection

Computer skills

Problem solving

Education

Bachelor's degree

B.S. preferred

Job description

Orchid Orthopedic Solutions Alabama seeks a Quality Engineer II to support the quality of legacy medical devices and collaborate with project management and manufacturing engineers on new production introductions and ongoing validation.

The role uses statistical methods, quality tools, and APQP deliverables to ensure product quality, CAPA effectiveness, and supplier quality support, with opportunities for training and growth.