Quality Engineer

Custom Wire Technologies • Port Washington, WI

26d

About The Position

Custom Wire Technologies (CWT), a growing family-owned manufacturer of precision medical components and devices, is hiring a Quality Engineer. The role helps ensure products and processes meet customer requirements, ISO 13485 standards, and CWT quality expectations. Reporting to the Quality Manager, the Quality Engineer works closely with manufacturing, engineering, and quality teams to improve processes, support product validation, investigate quality issues, and advance continuous improvement initiatives.

This position is primarily scheduled Monday through Friday during normal business hours, typically between 8:00 a.m. and 5:00 p.m. Occasional schedule flexibility may be required to support manufacturing operations and business needs. Regular physical attendance is required. Applicants must be authorized to work permanently in the United States; CWT does not provide employment sponsorship.

Requirements

• Bachelor of Science degree in engineering or a related field preferred, or equivalent experience.
• At least 3 years of related quality experience in an 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.
• Authorization to work permanently in the United States without current or future employment sponsorship.

Nice To Haves

• Medical technology and ISO 13485 experience.
• Medical device manufacturing 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, and vision coverage.
• Life and disability coverage.
• Paid time off.
• 401(k) with employer contribution.
• Profit sharing.
• Paid holidays.

What This Job Offers

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