QUALITY ENGINEER

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

About Cwt

Custom Wire Technologies (CWT) is a leading OEM medical component manufacturer, with over 50 years of industry experience and implementation of the latest technology. Our services include custom wire coiling, wire coiling, custom grinding, wire forming, custom fine wire design, fine wire welding, laser processing, and manufacturing process validation.

About Cwt

Custom Wire Technologies (CWT) is a leading OEM medical component manufacturer, with over 50 years of industry experience and implementation of the latest technology. Our services include custom wire coiling, wire coiling, custom grinding, wire forming, custom fine wire design, fine wire welding, laser processing, and manufacturing process validation.

We are a small, but growing family-owned and operated business. We are looking for a self-starter who has exceptional attention to detail, can adapt to changing priorities, and enjoys a dynamic work environment to fill the role of Quality Engineer.

Job Summary

Under the direction of the Quality Manager, the Quality Engineer is responsible for the materials in-process and finished products, ensuring conformance to ISO 13485 and company quality standards, and customer specifications. Aides in the development of processes and standards to provide departmental efficiencies and enhance company profitability.

Roles And 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 and existing products.
• Support the development and manufacturing of medical products, ensuring compliance with industry regulations.
• Provide leadership and guidance on quality assurance practices during the product lifecycle.
• Analyze quality data, identify problem areas, and assist in resolving manufacturing processes or methods that affect quality.
• Perform process capability studies; recommend changes to improve quality.
• Assist the organization in enforcing the Quality System and maintain consistent standards.
• Root cause analysis and implement corrective actions.
• Commit to the corporate goals, mission, and vision.
• Regular physical attendance is required.

Qualifications

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

Preferred

• ASQ quality certification
• Keyence, Micro Vu experience.
• Statistical background
• Experience working in a job shop manufacturing environment.

Job Hours

The Position responsibilities would primarily occur during the core hours of 8 am to 5 pm, Monday through Friday. Manufacturing operates on three shifts and this position will occasionally require extended hours as needed. Infrequent Travel.

Benefits

We offer a comprehensive benefits package including:

• Medical
• Dental
• Vision
• Life and disability
• Paid Time Off
• 401(k) with company match
• Profit Sharing
• Paid Holidays

At this time, we are not considering candidates that need any type of immigration sponsorship now or in the future to work in the United States.