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 1Manufacturing

**Professional Products Inc. does not sponsor employment visas for this position.**

Company Profile:

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.

Our Culture:

Professional Products is a family-owned company built on integrity innovation and accountability. We value a collaborative culture in which all functionsProduction Quality Regulatory Finance and Operationsactively 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 Position

The Quality and Process Improvement Engineer will be responsible for maintaining and advancing PPIs 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 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.

The position supports Production Purchasing Product Realization Finance and Regulatory Compliance while fostering collaboration across all company functions.

The PPI team comprises collaborative diverse and passionate professionals who take great pride in their work and are committed to helping others grow and develop. Youll have a platform to engage directly with decision-makers and influence both operational and strategic outcomes.

Required Knowledge

• 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).

Skills / Abilities:

• 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.

Job Description

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.The

Key Responsibilities:

• Maintain and continually improve PPIs 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 workflowsincluding 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.

The Successful Applicant

• Minimum 3 years of experience in Quality or Manufacturing Engineering.
• Minimum 3 years of experience working within ISO 13485 or ISO 9001 systems.
• 13 years of manufacturing experience preferably in process or quality engineering.
• Bachelors degree in an Engineering-related field.
• Demonstrated ability to work independently and cross-functionally in a dynamic environment.
• Interest in professional growth toward a Quality & Compliance Manager or Continuous Improvement Lead role.

Benefits

• Bonus Compensation
• Paid Holidays
• Vacation
• 401k
• Health Insurance

Professional Products is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability protected veteran status or any other characteristic protected by law.

Professional Products Inc. does not sponsor employment visas for this position.