Quality and Process Improvement Engineer

Quality and Process Improvement Engineer

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.

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. You'll have a platform to engage directly with decision-makers and influence both operational and strategic outcomes.

• 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.

• 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.
• 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.
• Interest in professional growth toward a Quality & Compliance Manager or Continuous Improvement Lead role.

• 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.