Quality Engineer — Lead Audits, FMEA & CAPA

Web Industries Inc; Fort Wayne (IN); On-site; USD 70,000 - 105,000; Full time

Job summary

Web Industries Inc. in Fort Wayne, IN is seeking a Quality Engineer to lead change management, FMEA/risk management, and QA validation activities. You will coordinate CAPA efforts, audits, data analysis, and supplier quality in cross-functional teams.

The ideal candidate has a BS in a scientific/technical field, 5+ years in quality roles, and strong communication to drive improvements and meet regulatory standards.

Qualifications

• Bachelor’s degree in a scientific or technical field or equivalent experience.
• Minimum of 5 years of experience in a quality-related role.
• Strong knowledge of quality assurance principles and practices, including change management, FMEA, risk management, internal auditing, data analysis, supplier auditing, and validation activities.
• Excellent analytical and problem-solving skills, with attention to detail and accuracy.
• Excellent communication, interpersonal, and leadership skills.
• Strong leadership skills to effectively lead cross-functional teams and drive quality initiatives.

Responsibilities

• Lead internal auditing activities, including conducting audits, identifying non-conformances, and tracking corrective actions.
• Lead FMEA and risk management activities, including identifying potential risks, developing mitigation plans, and monitoring risk reduction progress.
• Lead supplier auditing activities, including assessing supplier quality, identifying non-conformances, and tracking corrective actions.
• Lead change management initiatives, including identifying and prioritizing areas for improvement, creating action plans, and tracking progress.
• Lead investigations and root cause analysis of quality issues, implement corrective and preventive actions, and ensure timely closure of non-conformances.
• Review validation protocols to ensure that products, processes, and equipment are validated to meet regulatory requirements and quality standards.
• Participate in improvement projects to drive continuous improvement and enhance overall quality.
• Communicate with customers regarding quality-related issues, provide updates on quality performance, and respond to customer inquiries.
• Lead data analysis activities, including analyzing quality metrics, identifying trends, and developing recommendations for improvement.
• Performs any other function or responsibility as assigned

Skills

Quality assurance

FMEA & risk management

Internal auditing

Data analysis

Cross-functional leadership

Communication

Education

Bachelor’s degree in a scientific/technical field

ASQ CQE certification (preferred)

Job description

Web Industries Inc. in Fort Wayne, IN is seeking a Quality Engineer to lead change management, FMEA/risk management, and QA validation activities. You will coordinate CAPA efforts, audits, data analysis, and supplier quality in cross-functional teams.

The ideal candidate has a BS in a scientific/technical field, 5+ years in quality roles, and strong communication to drive improvements and meet regulatory standards.