Senior QA Manufacturing Engineer: Elevate Quality & Process

Arthrex; Ave Maria (FL); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Retirement Plan

Job summary

Arthrex, Inc. in Ave Maria, FL is seeking a Senior Quality Assurance Engineer for our manufacturing facility. This role supports the Quality Manager with QA across the lifecycle development of Class I–III medical devices, including new product development and ongoing product maintenance.

You will collaborate with cross-functional teams to ensure compliance and reliable manufacturing processes. The ideal candidate has a Bachelor’s degree in Engineering and at least 5 years in quality engineering

Qualifications

• Bachelor’s degree in Engineering required.
• 5 years quality engineering experience in a regulated industry required.

Responsibilities

• Support Quality Manager with life cycle QA for medical devices (Class I–III).
• Review design drawings for tolerance, inspect-ability and quality issues.
• Lead or support CAPA investigations and root cause analysis.
• Coordinate internal/external quality audits and risk assessments.
• Lead or participate in supplier process validations and IQ/OQ/PQ activities.
• Develop inspection methods and gage R&R studies.
• Support Continual Improvement projects and environmental monitoring.

Skills

Design controls

GD&T

DOE

Process verification

Process validation

SPC

Lean / Six Sigma

Risk assessments

PFMEA

Quality plans

Communication

Project management

Education

Bachelor’s degree in Engineering

Tools

Excel

Word

MiniTab

SAP

QMS software (Pilgrim or equivalent)

Agile life cycle software

Job description

Arthrex, Inc. in Ave Maria, FL is seeking a Senior Quality Assurance Engineer for our manufacturing facility. This role supports the Quality Manager with QA across the lifecycle development of Class I–III medical devices, including new product development and ongoing product maintenance.

You will collaborate with cross-functional teams to ensure compliance and reliable manufacturing processes. The ideal candidate has a Bachelor’s degree in Engineering and at least 5 years in quality engineering