Quality Engineer

As a Quality Engineer in Madison, WI, your responsibilities will include conducting product complaint investigations, performing root cause analyses, developing quality control processes, and managing supplier quality. You will also oversee CAPA and change control processes while supporting both internal and external audits. Your role will require close collaboration with teams across Operations, Engineering, and more, all aimed at fostering a robust culture of quality throughout the organization.

To apply for the Quality Engineer position at our Madison, WI facility, you should hold a Bachelor’s degree in Engineering, Science, or a related technical field, along with at least 3 years of experience in a cGMP-regulated Quality Assurance environment. Familiarity with statistical analysis, effective communication skills, and project management experience are also highly valued, while preferences include experience with medical device manufacturing and ASQ certification.

The Quality Engineer at our Madison, WI facility plays a vital role in ensuring regulatory compliance by interpreting and applying all applicable regulatory requirements. This includes maintaining quality processes that align with cGMP regulations, conducting audits, and managing documentation effectively. You will also support activities related to supplier quality management and lead investigations to uphold the highest standards of quality assurance.

Essential skills for a successful Quality Engineer at our Madison, WI facility include strong analytical abilities, effective communication, and technical writing skills. You should also possess problem-solving capabilities, project management experience, and a good grasp of statistical analysis tools. Leadership and emotional intelligence will enable you to navigate cross-functional teamwork and drive quality initiatives effectively.

The work environment for a Quality Engineer at our Madison, WI facility is dynamic and collaborative. You will primarily work in an office setting but may also spend time in manufacturing and laboratory areas. The pace can be fast, particularly when adhering to strict timelines, and the role may require occasional work outside standard business hours to meet business needs.

In approaching root cause analysis, I utilize a structured methodology such as the 5 Whys or Fishbone Diagram to identify underlying issues. Collaboration with cross-functional teams is crucial to gather diverse insights. I ensure thorough documentation of findings to support continuous improvement initiatives.

I have hands-on experience managing Corrective and Preventive Actions (CAPA). My approach involves identifying non-conformances, conducting investigations to pinpoint root causes, and implementing corrective actions while ensuring effectiveness checks are in place. Additionally, I keep stakeholders informed throughout the CAPA process.

I often use Microsoft Excel for basic analysis, but I’m also proficient in Minitab for more complex statistical evaluations. These tools help me assess data trends, conduct variance analysis, and support decisions based on quantitative evidence, all crucial for maintaining quality in manufacturing.

If a quality issue arises during production, I prioritize immediate investigation to assess the extent of the problem. I would collaborate with the production team to halt any processes if necessary, ensure a thorough root cause analysis is conducted, and implement effective corrective actions while communicating with all relevant stakeholders.

I promote a quality culture by actively engaging employees through training, workshops, and open discussions about quality concerns. Additionally, I recognize and celebrate quality achievements to encourage proactive involvement across departments in maintaining high-quality standards.

I address supplier quality issues by conducting thorough evaluations, including audits and quality agreement assessments. Open communication is essential to work collaboratively with suppliers to develop corrective actions and continuous improvement plans while ensuring compliance with quality standards.

One successful project I led involved streamlining our quality control process, which reduced audit findings by 30%. By implementing standardized procedures and training sessions for the team, we improved consistency in our practices and fostered a culture of accountability.

A significant challenge I’ve faced was navigating changes in regulatory requirements. To address this, I established a continuous training program for our team to stay updated on compliance, which helped minimize disruptions and maintain our quality standards.

I have conducted numerous internal audits to ensure compliance with our quality systems, focusing on identifying areas for improvement. My experience with external audits includes preparing for inspections, coordinating responses to findings, and implementing corrective actions to rectify deficiencies.

To stay current with industry regulations and standards, I regularly participate in professional development programs, subscribe to relevant publications, and engage with professional organizations like ASQ. Networking with industry peers also provides insights into best practices and regulatory updates.