Ezy Wrap · 2 months ago
Quality and Process Improvement Engineer
DeFuniak Springs, FL
Full-time
Onsite
Mid Level
3+ years expProfessional Products Inc. is an international medical device manufacturing and distribution corporation. The Quality and Process Improvement Engineer will be responsible for maintaining and advancing the ISO 13485:2016 Quality Management System and driving cross-functional process improvement initiatives.
E-CommerceHealth CareManufacturingMedical
No H1B
Responsibilities
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
Qualification
Required
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
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
Demonstrated ability to work independently and cross-functionally in a dynamic environment
Preferred
Interest in professional growth toward a Quality & Compliance Manager or Continuous Improvement Lead role
Benefits
Bonus Compensation
Paid Holidays
Vacation
401k
Health Insurance
Company
Ezy Wrap
Professional Products, Incorporated (PPI) has been designing and developing innovative and cost-efficient orthopaedic medical products for over 50 years.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase