QUALITY ENGINEER

Cwt Custom Wire Technologies (CWT) is a leading OEM medical component manufacturer with over 50 years of industry experience. Our services include custom wire coiling, grinding, wire forming, fine wire design, welding, laser processing, and manufacturing process validation. We are a small, growing, family-owned business.

About the role

Under the direction of the Quality Manager, the Quality Engineer ensures materials, in-process, and finished products conform to ISO 13485, company quality standards, and customer specifications. This role aids in developing processes and standards to improve departmental efficiencies and enhance company profitability.

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 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.
• Perform root cause analysis and implement corrective actions.
• Commit to corporate goals, mission, and vision.
• Regular physical attendance is required.

Requirements

• Bachelor of Science degree in Engineering or related field preferred.
• 3+ years of related quality experience in an ISO manufacturing environment; med tech and ISO 13485 experience preferred.
• Strong knowledge and experience performing 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 ability to perform root cause analysis.

Preferred Qualifications

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

Schedule

Core hours are 8 am to 5 pm, Monday through Friday. Manufacturing operates on three shifts, and this position may occasionally require extended hours as needed. Infrequent travel is required.

Benefits

• Medical, dental, and vision coverage.
• Life and disability insurance.
• Paid Time Off.
• 401(k) with company match.
• Profit sharing.
• Paid holidays.

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