We are seeking an experienced Quality Engineer with a strong background in quality systems and manufacturing of small, tight-tolerance precision components. This role is responsible for driving product quality, reducing process variation, leading root cause investigations, and implementing continuous improvement initiatives in a manufacturing environment.

Key Responsibilities:

Lead quality improvement initiatives using root cause analysis, CAPA, PFMEA, Control Plans, SPC, and 5-Why methodologies. Support manufacturing processes by developing standard work, validating equipment (IQ/OQ/PQ), and improving process capability. Manage customer validation projects, including process flow diagrams, MSA studies, initial process studies, and performance testing. Conduct internal audits, review findings, implement corrective actions, and maintain compliance with

ISO 13485, ISO

9001, and AS9100 quality standards. Develop quality metrics and KPIs, support management reviews, and analyze quality trends to reduce scrap and process failures. Collaborate with Engineering, Manufacturing, Maintenance, and Operations to resolve technical issues and improve product quality.

Qualifications:

Bachelor's degree in Mechanical Engineering, Aerospace Engineering, or a related field. Experience in a precision machining or manufacturing environment producing tight-tolerance components. Strong knowledge of

ISO 13485, ISO

9001, AS9100, CAPA, auditing, GD&T, and quality management systems. Experience with PFMEA, Control Plans, SPC, MSA, and equipment validation (IQ/OQ/PQ). ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) preferred. Excellent analytical, problem-solving, communication, and continuous improvement skills.

Pay:

$70,000.00 - $95,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance Ability to

Commute:

Cleveland, OH 44109 (Required)

Work Location:

In person