QUALITY ENGINEER

Custom Wire Technologies • Port Washington, WI

28d • Onsite

About The Position

Custom Wire Technologies (CWT) is seeking a Quality Engineer to join their growing, family-owned medical component and device manufacturing team. This role is crucial for ensuring products and processes meet customer requirements, ISO 13485 standards, and CWT quality expectations. The Quality Engineer will collaborate closely with manufacturing, engineering, and quality teams to enhance processes, support product validation, investigate quality issues, and drive continuous improvement. This position offers an opportunity to make a direct impact in a stable company where ideas are valued and contributions are recognized.

Requirements

• Bachelor of Science degree - Engineering or related field preferred, or equivalent experience.
• 3+ years related quality experience in ISO manufacturing environment
• Strong problem-solving and analytical skills.
• Ability to read and interpret engineering drawings and specifications.
• Proven ability to manage multiple projects and priorities.
• Applicants must be authorized to work in the United States on a permanent basis.

Nice To Haves

• Medical device manufacturing experience
• ISO 13485 experience
• ASQ quality certification (CQE, CQT, or similar)
• Experience with Keyence or Micro Vu inspection systems.
• Statistical analysis and process capability experience
• Experience working in a job shop or custom manufacturing environment.

Responsibilities

• Lead and support equipment, process, and product validations (IQ, OQ, PQ)
• Develop, implement, and improve quality procedures and work instructions
• Program and operate vision inspection systems
• Analyze quality data and identify opportunities for process improvement
• Perform process capability studies and recommend corrective actions
• Investigate quality concerns using root cause analysis techniques
• Support corrective and preventive action activities
• Ensure compliance with ISO 13485 and company quality standards
• Collaborate with manufacturing teams to improve product quality and efficiency
• Assist with new product introductions and process development
• Support audits and quality system initiatives

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level