Quality Engineer - Med Tech | ISO 13485

Custom Wire technologies, Inc.; Port Washington (WI); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life and disability

Paid Time Off

401(k) with company match

Profit Sharing

Paid Holidays

Job summary

Custom Wire Technologies (CWT) is seeking a Quality Engineer to ensure conformance to ISO 13485 and company quality standards while supporting medical product development and manufacturing.

Under the direction of the Quality Manager, you will develop and validate processes, program vision inspection systems, and lead quality initiatives across the product lifecycle. This full-time on-site role requires attention to detail and strong problem-solving skills.

Qualifications

• Bachelor of Science degree in Engineering or related field preferred.
• 3+ years of quality experience in ISO manufacturing environment, med tech and ISO 13485 preferred.
• Strong knowledge to perform validations and qualifications of products and processes.
• Ability to analyze and interpret blueprints.
• Proven experience managing multiple projects and meeting deadlines.
• Strong problem-solving skills and root-cause analysis abilities.

Responsibilities

• Develop, implement, and improve technical procedures related to quality control and product validation.
• Program and operate Vision System inspection machines.
• Lead and participate in validation activities (IQ, OQ, PQ) for equipment and new/existing products.
• Support development and manufacturing of medical products, ensuring regulatory compliance.
• Provide leadership on quality assurance practices during the product lifecycle.
• Analyze quality data, identify problem areas, and assist in resolving manufacturing process issues.
• Perform process capability studies; recommend changes to improve quality.
• Assist in enforcing the Quality System and maintaining standards.
• Root cause analysis and implement corrective actions.

Skills

Quality engineering

ISO 13485

Validation

Root cause analysis

Process improvement

Project management

Education

Bachelor of Science in Engineering

Tools

Vision inspection systems

Statistical analysis

Job description

Custom Wire Technologies (CWT) is seeking a Quality Engineer to ensure conformance to ISO 13485 and company quality standards while supporting medical product development and manufacturing.

Under the direction of the Quality Manager, you will develop and validate processes, program vision inspection systems, and lead quality initiatives across the product lifecycle. This full-time on-site role requires attention to detail and strong problem-solving skills.