QUALITY ENGINEER | Medical Device Manufacturing | Port Washington, WI

About the role

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. Regular physical attendance is required.

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

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.
• 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.

Benefits

• Medical
• Dental
• Vision
• Life and disability
• Paid Time Off
• 401(k) with employer contribution
• Profit Sharing
• Paid Holidays
• Family-owned company with nearly 25 years of success
• Stable and growing business serving the medical device industry
• Small-company environment where your contributions are recognized
• Opportunity to work on a wide variety of quality, validation, and process improvement projects
• Collaborative team culture with direct access to leadership
• Proudly located in Port Washington, Wisconsin

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.