Quality Engineer

POSITION SUMMARY

The Quality Engineer is responsible for leading change management, leading FMEA and risk management, leading internal auditing, leading data analysis, leading supplier auditing, leading QA related validation activities including reviewing and approving validation plans, and coordinating CAPA activities. The ideal candidate will be knowledgeable about quality assurance principles and practices, have excellent communication skills, and be able to lead cross-functional teams.

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

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

Additional REQUIRED Qualifications/Skills:

1. Bachelor’s degree in a scientific or technical field or equivalent experience

2. Minimum of 5 years of experience in a quality-related role

3. Strong knowledge of quality assurance principles and practices, including change management, FMEA, risk management, internal auditing, data analysis, supplier auditing, and validation activities.

4. Excellent analytical and problem-solving skills, with attention to detail and accuracy.

5. Excellent communication, interpersonal, and leadership skills.

6. Strong leadership skills to effectively lead cross-functional teams and drive quality initiatives.

Additional PREFERRED Qualifications/Skills:

1. ASQ certification (CQE)

2. Experience with statistical process control (SPC) and Six Sigma methodologies.

3. Six Sigma certification.

4. Experience with training and coaching to ensure that employees are knowledgeable and compliant with quality standards and procedures.