Quality Engineer

Job Overview – Quality Engineer

The Quality Engineer plays a critical role in supporting quality assurance, compliance, and continuous improvement initiatives within a contract manufacturing environment specializing in electromechanical assemblies, cable and harness builds, and related products. This position works cross-functionally with Production, Engineering, Quality Control, and customers to ensure products and processes consistently meet internal standards, customer requirements, and ISO 9001 / ISO 13485 regulations.

The Quality Engineer is responsible for leading corrective and preventive action activities, supporting root cause investigations, conducting internal audits, and analyzing quality performance data to drive operational improvements. This role also supports customer quality programs, RMA and field failure investigations, employee training initiatives, and ongoing process enhancements that improve product reliability and manufacturing efficiency.

The ideal candidate combines strong technical knowledge of manufacturing quality systems with hands-on problem-solving abilities, effective communication skills, and experience working in regulated electromechanical manufacturing environments.

Key Responsibilities

• Support RMA and field failure investigations, including defect analysis and customer failure analysis reporting.
• Lead and support CAPA activities, root cause analysis, and corrective action implementation.
• Develop and support quality improvement initiatives, employee training, and quality process documentation.
• Provide technical guidance and troubleshooting support to Quality, Engineering, and Production teams.
• Plan, conduct, and report internal audits to ensure compliance with ISO 9001 and ISO 13485 standards.
• Assist with first article, in-process, and final inspection activities as needed.
• Support customer quality requirements, audits, and quality performance communication.
• Analyze quality metrics, defect trends, supplier performance, and process data to identify improvement opportunities.
• Maintain accurate quality documentation and support regulatory compliance initiatives.

Qualifications

• Associate or Bachelor’s Degree in Engineering, Quality, or a related technical field, or equivalent industry experience.
• Minimum 2\+ years of experience in a Quality role within manufacturing or contract manufacturing environments.
• Strong understanding of QA/QC principles, ISO 9001, ISO 13485, IPC-A-610, and related quality standards.
• Experience with root cause analysis methodologies such as 5 Whys, Fishbone, and 8D.
• Familiarity with inspection and testing processes for electromechanical assemblies.
• Strong analytical, organizational, documentation, and problem-solving skills.
• Proficiency with Microsoft Office and quality tracking or reporting systems.
• Excellent written and verbal communication skills with the ability to work cross-functionally.

Preferred Qualifications

• ISO 9001 and/or ISO 13485 Internal Auditor certification.
• Experience using CAPA management systems.
• Exposure to Lean Manufacturing or Six Sigma methodologies.
• Knowledge of ERP/MRP systems and electronic document control processes.

Pay: $85,000\.00 - $92,000\.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person