Quality and Process Improvement Engineer

Key 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.
• Cook up 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.

Requirements

• 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.

Qualifications

• 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.

Benefits

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