Quality Engineer: CI, Audits & Customer Quality

Advanex Americas, Inc.; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

Advanex Americas, Inc. in White House, TN is seeking a Quality Engineer for a full-time, on-site role focused on quality performance, continuous improvement, and customer confidence.

You will partner across engineering, production, suppliers and customers to resolve issues and elevate standards. The successful candidate will maintain and improve the quality management system, lead investigations into customer complaints, and support internal audits to ensure ISO-compliant processes and ongoing

Qualifications

• Bachelor's degree in Engineering or related field is required.
• 3-5 years experience in a quality or manufacturing engineering environment.
• Medical device manufacturing experience preferred.
• Strong analytical and problem solving skills required.
• Knowledge of Lean Manufacturing and continuous improvement methodologies.
• Experience with ISO-based quality systems and audits.
• Experience with PLEX preferred.
• Strong organizational, project management and time management skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Intermediate/Advanced Microsoft Excel skills.

Responsibilities

• Serve as the primary point of contact for customer quality concerns, ensuring prompt response and resolution.
• Lead investigations into customer complaints, including containment, root cause analysis, corrective actions and communication with customers and suppliers.
• Maintain and monitor customer compliant databases and customer-specific requirements to ensure ongoing compliance.
• Support the production floor with data analysis, troubleshooting, and root cause investigations.
• Lead internal cross-functional meetings to drive corrective and preventative actions.
• Provide guidance and training to technicians on quality tools such as SPC, Kaizen, QC methods and problem-solving techniques.
• Participate in continuous improvement initiatives to enhance manufacturing quality and efficiency.
• Participate in new product launches, ensuring customer and supplier submissions are accurate and completed on time.
• Develop and maintain control plans and inspection plans, reviewing and updating annually or as needed.
• Communicate quality requirements to suppliers and collaborate with Purchasing on supplier improvement initiatives.

Skills

Analytical skills

Problem solving

Time management

Independence

Education

Bachelor's degree in Engineering or related field

Tools

PLEX

Excel

Job description

Advanex Americas, Inc. in White House, TN is seeking a Quality Engineer for a full-time, on-site role focused on quality performance, continuous improvement, and customer confidence.

You will partner across engineering, production, suppliers and customers to resolve issues and elevate standards. The successful candidate will maintain and improve the quality management system, lead investigations into customer complaints, and support internal audits to ensure ISO-compliant processes and ongoing