Quality Technician - CAPA, FAI & Supplier Quality

Aspen-Surgical; Caledonia (MI); On-site; USD 70,000 - 100,000; Full time

Job summary

Aspen-Surgical is seeking a Quality Engineer to support validation and risk activities with manufacturing and engineering teams. You will investigate customer complaints, perform root cause analysis, and drive corrective actions to improve product quality.

The role requires collaboration across functions, strong communication, and the ability to manage multiple projects while adhering to FDA/ISO requirements. On-site work with a focus on continuous improvement.

Qualifications

• High School Diploma or equivalent required.
• 3+ years of experience in quality improvement projects preferred.
• 3+ years in a regulated industry with FDA/ISO requirements preferred.

Responsibilities

• Support validation and risk build activities with manufacturing and engineering.
• Perform Customer Complaint Investigations, including dispositions and quality communications.
• Perform root cause analysis and implement effective corrective actions.
• Initiate non-conforming dispositions.
• Initiate CRs and COs.
• Write, train and ensure implementation of Quality Alerts, rework instructions and planned deviations.
• Maintain and update Control Plans in IFS.
• Maintain supplier relationships and drive continuous improvement.
• Participate with Supply Chain in supplier selection and cost reduction.
• Perform FAI for new products and changes.
• Maintain supplier quality files and conduct audits per QMS.
• Identify process improvements with manufacturing to enhance product quality.
• Analyze MRB improvement opportunities.
• Develop trainings to build quality awareness.
• Support manufacturing and engineering to resolve technical issues.

Skills

Communication

Teamwork

Problem Solving

Project Management

Reading Drawings

Microsoft Office

IFS

EtQ

Flexibility

Education

High School Diploma or equivalent

Tools

Microsoft Office Suite

IFS

EtQ

Job description

Aspen-Surgical is seeking a Quality Engineer to support validation and risk activities with manufacturing and engineering teams. You will investigate customer complaints, perform root cause analysis, and drive corrective actions to improve product quality.

The role requires collaboration across functions, strong communication, and the ability to manage multiple projects while adhering to FDA/ISO requirements. On-site work with a focus on continuous improvement.