QMS Engineer

Job Summary

QMS Engineer

USI / Asteelflash is seeking a highly skilled and experienced Quality Management Systems (QMS) Engineer to oversee, maintain, and continuously improve our Quality Management Systems across both New Product Introduction (NPI) and sustaining production programs.

This role is pivotal in ensuring compliance with ISO 9001, IATF 16949, ISO 13485, and ISO 14001 standards, driving continuous improvement initiatives, and maintaining the highest quality standards within our electronics contract manufacturing operations. The successful candidate will collaborate with cross-functional teams to strengthen quality processes, support audits, enhance operational performance, and ensure customer and regulatory compliance.

Key Responsibilities

• Develop, implement, maintain, and continuously improve Quality Management Systems in accordance with ISO 9001, IATF 16949, ISO 13485, ISO 14001, customer, and regulatory requirements.
• Plan, conduct, and lead internal, external, certification, customer, and supplier audits to ensure compliance with applicable standards and customer-specific requirements.
• Manage and oversee the Corrective and Preventive Action (CAPA) process, ensuring timely resolution of nonconformances and verification of effectiveness.
• Maintain controlled QMS documentation, including procedures, work instructions, forms, and records, ensuring accuracy, accessibility, and compliance.
• Develop and deliver training programs on quality standards, procedures, and best practices to promote a quality-focused culture throughout the organization.
• Monitor, analyze, and report Quality Management System performance metrics and KPIs, identifying opportunities for improvement.
• Partner closely with Engineering, Manufacturing, Supply Chain, and Operations teams to integrate quality requirements into all business processes.
• Lead root cause investigations using quality tools such as 8D, 5 Why, FMEA, SPC, and APQP.
• Support Management Review activities and prepare quality performance reports.
• Stay current on changes to applicable industry standards, regulatory requirements, and customer expectations, ensuring ongoing organizational compliance.
• Drive continuous improvement initiatives that reduce defects, improve process efficiency, and enhance customer satisfaction.

Minimum QualificationsEducation

• Bachelor's degree in Engineering, Quality Management, Industrial Engineering, Manufacturing Engineering, or a related field.

Experience

• Minimum of 5–10 years of Quality Management Systems experience within an electronics contract manufacturing (EMS) environment.
• Demonstrated experience implementing and maintaining ISO-based management systems and supporting certification audits.

Certifications

• ISO 9001 Lead Auditor Certification (required).
• ISO 14001 Internal or Lead Auditor Certification (preferred).
• IATF 16949 Internal or Lead Auditor Certification (preferred).
• ISO 13485 Internal or Lead Auditor Certification (preferred).
• ISO 45001 Auditor Certification (a plus).

Technical Skills

• Strong working knowledge of ISO 9001, IATF 16949, ISO 13485, and ISO 14001 standards.
• Proficiency with quality methodologies and tools, including:
• 8D Problem Solving
• FMEA
• SPC
• APQP
• Root Cause Analysis
• Corrective and Preventive Action (CAPA)
• Advanced proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, and Project).

Additional Skills

• Excellent verbal and written communication skills, including technical report writing.
• Strong English writing and presentation skills.
• Proven training and facilitation skills.
• Ability to effectively influence and collaborate across all organizational levels.
• Demonstrated ability to manage multiple priorities and resolve issues within tight deadlines.
• Strong analytical thinking and problem-solving capabilities.

Preferred Qualifications

• Experience in automotive, medical device, or highly regulated manufacturing environments.
• Lean Manufacturing and/or Six Sigma certification.
• Experience with electronic document management systems (eDMS) and quality management software.

Pay: $120,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Work Location: In person