Quality and Process Improvement Engineer

Quality and Process Improvement Engineer

• Position: Quality and Process Improvement Engineer
• Modality: Full-Time, Salary, In-Person
• Location: Defuniak Springs, FL
• Industry: Medical Device, Class 1, Manufacturing
• Professional Products, Inc. does not sponsor employment visas for this position.

Since starting in a single-window store in the Florida panhandle in 1963, Professional Products Inc. (PPI) has grown into an international medical device manufacturing and distribution corporation. Our products are the market leader in integrated cold therapy, user‑comfort‑based material science, and patient safety through advanced antimicrobial technology. PPI enables innovation with vertically integrated domestic U.S. operations, a spirit of entrepreneurship, and operational agility.

Professional Products is a family‑owned company built on integrity, innovation, and accountability. We value a collaborative culture in which all functions—Production, Quality, Regulatory, Finance, and Operations—actively participate in executing our strategic vision. We encourage initiative and independent problem‑solving, empowering our team members to take ownership and translate company goals into tangible, measurable results.

The Quality and Process Improvement Engineer will be responsible for maintaining and advancing PPI’s ISO 13485:2016 Quality Management System (QMS) and driving cross‑functional process improvement initiatives. This role balances 50% quality management and 50% process improvement, serving as a key bridge between operational functions. In addition to sustaining QMS compliance, the engineer will lead initiatives that enhance business processes such as medical billing for insurance reimbursement, operational compliance, and data‑driven improvement projects.

• Strong working knowledge of the ISO 13485:2016 or ISO 9001 standards.
• Understanding of Quality Management System concepts, including RCCA, CAPA, Process Validation, and Process Control.
• Familiarity with Power BI, SQL, Excel, and Microsoft Business Central for data analysis and reporting.
• Strong professional proficiency in the Microsoft Suite (Outlook, Word, Excel).

• Strong initiative and ability to drive independent projects to completion.
• Quality‑oriented and attentive to detail while balancing speed and practicality.
• Excellent analytical, communication, and cross‑functional collaboration skills.
• Ability to translate strategic objectives into actionable improvement projects.
• Strong organizational, time management, and problem‑solving abilities.

The Quality and Process Improvement Engineer reports to the Chief Commercial and Operations Officer.

Internal relationships include Production, Purchasing, Research and Design, Programming, Finance, and Executive Management in DeFuniak Springs, FL. External relationships may include commercial collaborations with partners, distributors, customers, and suppliers.

• Maintain and continually improve PPI’s ISO 13485:2016 certification and QMS as the Management Representative.
• Lead Corrective and Preventive Action (CAPA) processes: initiation, root cause analysis, action implementation, and validation.
• Drive process improvement initiatives across Quality, Operations, and Administrative workflows—including medical billing and insurance compliance.
• Manage responses for customer complaints, investigations, and returns analysis.
• Coordinate with suppliers for Supplier Corrective Action Reports (SCARs).
• Perform quality containment for defective products and communicate quality alerts.
• Assess and disposition non-conformances in production.
• Provide quality and compliance training and coaching to other departments.
• Manage calibration records and ensure equipment compliance with QMS requirements.
• Conduct internal quality system, product, and process audits supporting continual improvement.
• Establish and track Quality KPIs and lead Management Review data preparation.
• Partner with cross‑functional teams to identify, implement, and measure process improvement outcomes.

• Minimum 3 years of experience in Quality or Manufacturing Engineering.
• M…