Senior QA Engineer – Medical Devices (Onsite + Benefits)

Miami Neuroscience Institute Baptist Health South Florida; Ave Maria (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Tuition Reimbursement Program

Paid Time Off

Job summary

Arthrex, Inc. seeks a Senior Quality Assurance Engineer for its Ave Maria, FL facility. The role supports the Quality Manager across life cycle development of Class I–III medical devices, including new product development and maintenance of released products.

Key duties include leading risk assessments, supplier quality, inspection method development, and CAPA. The position requires a engineering degree and 5+ years in quality engineering within regulated environments.

Qualifications

• Bachelor's degree in Engineering is required.
• At least 5 years of quality engineering experience in a regulated industry.
• Knowledge of Design Controls, GD&T, DOE, and process verification/validation.
• Experience with PFMEAs, control plans, and CAPA activities.
• Strong communication and project management skills.

Responsibilities

• Review design drawings for tolerance and inspectability.
• Lead or support design validation and process validation activities.
• Support risk management by leading PFMEAs and risk assessments.
• Assist in internal and external quality audits as directed.
• Lead or support measurement system analysis (Gage R&R) studies.
• Create inspection methods and work instructions.
• Investigate complaints and drive NCR closures.
• Support continuous improvement projects and environmental monitoring.

Skills

Quality engineering

Design Controls

GD&T

DOE

Process Verification

Validation

Risk Management

CAPA

Statistical analysis

Project management

Education

Bachelor's degree in Engineering

Tools

Excel

Minitab

Word

SAP

Pilgrim QMS

Agile

Job description

Arthrex, Inc. seeks a Senior Quality Assurance Engineer for its Ave Maria, FL facility. The role supports the Quality Manager across life cycle development of Class I–III medical devices, including new product development and maintenance of released products.

Key duties include leading risk assessments, supplier quality, inspection method development, and CAPA. The position requires a engineering degree and 5+ years in quality engineering within regulated environments.