Medical Device Assembly Technician—Quality & Process

Intepros; Tempe (AZ); On-site; USD 65,000 - 90,000; Full time

Job summary

IntePros is seeking an Medical Device Assembly Technician in Tempe, AZ to provide engineering support in inspection, non-conforming materials, and quality issue resolution. The role includes assisting with production process audits, supplier CAPAs, and documentation while upholding GMP/ISO standards.

The ideal candidate has a engineering background, experience with ISO/GMP environments, and strong problem-solving skills.

Qualifications

• Bachelor’s degree in Engineering or a related field from an accredited four-year institution, or equivalent relevant work experience.
• Previous manufacturing, engineering, or quality experience is beneficial.
• Experience working within ISO- and GMP-regulated manufacturing environments preferred.

Responsibilities

• Perform and recommend quality controls, process testing, and corrective actions to maintain product/process integrity.
• Troubleshoot and resolve quality issues related to production orders and manufacturing processes.
• Monitor and analyze product quality data to identify trends and support root cause analysis.
• Conduct Cp/Cpk, DOE, FAI, and other studies for mold and process qualification.
• Support engineering teams in developing and refining quality plans, procedures, and systems.
• Provide project updates to internal and external stakeholders.
• Assist with project planning, including schedules, budgets, and progress tracking.
• Support Lean Six Sigma and continuous improvement initiatives to improve quality and manufacturing performance.
• Follow SOPs, GMP requirements, ISO standards, safety policies, and company regulations.
• Maintain accurate documentation and communicate project status to management.
• Provide high level customer service when working with stakeholders.
• Maintain a clean, organized, and safe work environment.

Skills

Quality tools

Cp/Cpk

DOE

First Article Inspections

Analytical problem-solving

Microsoft Office

Cross-functional teamwork

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Job description

IntePros is seeking an Medical Device Assembly Technician in Tempe, AZ to provide engineering support in inspection, non-conforming materials, and quality issue resolution. The role includes assisting with production process audits, supplier CAPAs, and documentation while upholding GMP/ISO standards.

The ideal candidate has a engineering background, experience with ISO/GMP environments, and strong problem-solving skills.