Quality Engineer: FMEA, Audits & CAPA Leader

Web-Industries-; Fort Wayne (IN); On-site; USD 80,000 - 105,000; Full time

Job summary

Web-Industries- in Fort Wayne, IN is seeking a Quality Engineer to lead change management, FMEA, risk management and internal auditing, coordinating CAPA activities and QA validation efforts.

The ideal candidate holds a Bachelor’s degree in a scientific or technical field with 5+ years in quality roles, plus strong analytical, communication, and leadership skills to drive cross-functional improvements and supplier quality initiatives.

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 principles

Change management

FMEA

Risk management

Internal auditing

Data analysis

Supplier auditing

Validation activities

Communication skills

Leadership

Education

Bachelor's degree in a scientific or technical field or equivalent experience

Job description

Web-Industries- in Fort Wayne, IN is seeking a Quality Engineer to lead change management, FMEA, risk management and internal auditing, coordinating CAPA activities and QA validation efforts.

The ideal candidate holds a Bachelor’s degree in a scientific or technical field with 5+ years in quality roles, plus strong analytical, communication, and leadership skills to drive cross-functional improvements and supplier quality initiatives.