QUALITY ENGINEER

Custom Wire Technologies•Port Washington, WI

6d•Onsite

About The Position

Under the direction of the Quality Manager, the Quality Engineer is responsible for the materials in-process and finished products, ensuring conformance to ISO 13485 and company quality standards, and customer specifications. Aides in the development of processes and standards to provide departmental efficiencies and enhance company profitability.

Requirements

Bachelor of Science degree - Engineering or related field preferred.
3+ years related quality experience in ISO manufacturing environment, med tech and ISO 13485 experience preferred.
Strong knowledge and experience to perform validations and qualifications of products and processes.
Ability to analyze and interpret blueprints.
Proven experience with ability to manage multiple projects and meet deadlines.
Strong problem-solving skills and ability to perform root cause analysis.

Nice To Haves

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

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 and 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.
Root cause analysis and implement corrective actions.
Commit to the corporate goals, mission, and vision.
Regular physical attendance is required.