Drive Quality Excellence in Medical ManufacturingCustom Wire Technologies (CWT) is a growing, family-owned manufacturer of precision medical components and devices. For more than 50 years, we've partnered with leading medical technology companies to produce high-quality components used in life-changing medical products. We're looking for a Quality Engineer who enjoys solving problems, improving processes, and working closely with manufacturing teams to ensure the highest levels of product quality. If you're looking for a stable company where your work matters, your ideas are valued, and you can make a direct impact on product quality and customer satisfaction, we'd love to hear from you. Why Join CWT?Family-owned company with nearly 25 years of successStable and growing business serving the medical device industrySmall-company environment where your contributions are recognizedOpportunity to work on a wide variety of quality, validation, and process improvement projectsCollaborative team culture with direct access to leadershipCompetitive benefits package, 401(k) employer contribution, and profit sharingProudly located in Port Washington, Wisconsin Position Overview:Reporting to the Quality Manager, the Quality Engineer helps ensure our products and processes meet customer requirements, ISO 13485 standards, and CWT quality expectations. This role partners closely with manufacturing, engineering, and quality teams to improve processes, support product validation activities, investigate quality issues, and drive continuous improvement initiatives. Key Responsibilities: Lead and support equipment, process, and product validations (IQ, OQ, PQ)Develop, implement, and improve quality procedures and work instructionsProgram and operate vision inspection systemsAnalyze quality data and identify opportunities for process improvementPerform process capability studies and recommend corrective actionsInvestigate quality concerns using root cause analysis techniquesSupport corrective and preventive action activitiesEnsure compliance with ISO 13485 and company quality standardsCollaborate with manufacturing teams to improve product quality and efficiencyAssist with new product introductions and process developmentSupport audits and quality system initiativesRegular physical attendance is required. Qualifications: Bachelor of Science degree - Engineering or related field preferred, or equivalent experience.3+ years related quality experience in ISO manufacturing environment; med tech and ISO 13485 experience preferred.Strong problem-solving and analytical skills.Ability to read and interpret engineering drawings and specifications.Proven ability to manage multiple projects and priorities. PREFERRED: Medical device manufacturing experienceISO 13485 experienceASQ quality certification (CQE, CQT, or similar)Experience with Keyence or Micro Vu inspection systems.Statistical analysis and process capability experienceExperience working in a job shop or custom manufacturing environment. Schedule: 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. Benefits: CWT offers a comprehensive benefits package including:MedicalDentalVisionLife and disabilityPaid Time Off401(k) with employer contributionProfit SharingPaid Holidays Work Authorization:Applicants must be authorized to work in the United States on a permanent basis. CWT does not provide employment sponsorship now or in the future. 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.