Quality & Process Improvement Engineer – ISO 13485 Specialist

Professional Products, Inc.; DeFuniak Springs (FL); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Bonus Compensation

Paid Holidays

Vacation

401k

Health Insurance

Job summary

Professional Products, Inc. invites applications for a Quality and Process Improvement Engineer in Defuniak Springs, FL. The role balances quality management with process improvement initiatives and serves as a bridge between Production, Purchasing, Finance, and Regulatory Compliance.

You will sustain QMS compliance, lead CAPA activities, and drive data-driven improvements across operations. A bachelor’s degree in engineering and 3+ years in quality/ manufacturing are required.

Qualifications

• Minimum 3 years of experience in Quality or Manufacturing Engineering.
• Minimum 3 years of experience working within ISO 13485 or ISO 9001 systems.
• 1–3 years of manufacturing experience, preferably in process or quality engineering.
• Bachelor’s degree in an Engineering-related field.

Responsibilities

• Maintain and continually improve ISO 13485:2016 certification and QMS as the Management Representative.
• Lead CAPA processes: initiation, root cause analysis, action implementation, and validation.
• Drive cross-functional process improvement—Quality, Operations, and Administrative workflows.
• Manage responses for customer complaints, investigations, and returns analysis.
• Coordinate with suppliers for corrective action reports (SCARs).
• Provide quality and compliance training and coaching to other departments.
• Establish and track Quality KPIs and lead data preparation for Management Review.

Skills

ISO 13485 knowledge

RCCA / CAPA

Process Validation

Process Control

Cross-functional collaboration

Data analysis

Education

Bachelor’s degree in Engineering

Tools

Power BI

SQL

Excel

Microsoft Business Central

Job description

Professional Products, Inc. invites applications for a Quality and Process Improvement Engineer in Defuniak Springs, FL. The role balances quality management with process improvement initiatives and serves as a bridge between Production, Purchasing, Finance, and Regulatory Compliance.

You will sustain QMS compliance, lead CAPA activities, and drive data-driven improvements across operations. A bachelor’s degree in engineering and 3+ years in quality/ manufacturing are required.