ISO 9001 Quality Assurance Leader (Manufacturing)

Prototek Digital Manufacturing; Menomonie (WI); On-site; USD 75,000 - 110,000; Full time

Job summary

Prototek Digital Manufacturing in Wisconsin is seeking a Quality Assurance Manager to develop, implement, and maintain the QMS to ensure ISO 9001 compliance and meet customer requirements. You will lead quality initiatives and drive continuous improvement across the organization.

Responsibilities include managing audits, CAPA, NCR, calibration systems, and training teams on quality processes while partnering with operations and engineering to analyze data and implement process improvements.

Qualifications

• Degree in Business, Manufacturing, engineering, Quality, or related field.
• 5+ years’ experience in a quality discipline or experience with quality systems.
• 5+ years’ experience in manufacturing industry required.
• Experience with audits, CAPA, and continuous improvement tools.
• Leadership experience managing teams or programs.
• Ability to read and interpret technical drawings.
• Strong knowledge of ISO 9001 standards.
• ERP experience (Mie Trak a plus).

Responsibilities

• Develop and maintain the site Quality Management System (QMS).
• Ensure compliance with ISO 9001 and customer/regulatory requirements.
• Lead internal and external audits and corrective action processes.
• Manage Non-Conformance (NCR) and CAPA programs.
• Oversee inspection criteria, documentation, and calibration systems.
• Train teams on quality processes and standards.
• Partner cross-functionally with operations and engineering.
• Analyze quality data and implement process improvements.

Skills

Quality management

Audits

CAPA

Leadership

Data analysis

Reading drawings

Education

Bachelor's degree in Business/Manufacturing/Engineering/Quality

Tools

Mie Trak ERP

Job description

JOB TITLE: Quality Assurance Manager (ISO 9001 | Manufacturing)

PAY RANGE: $75,000 – $110,000 | SHIFT: 1st Shift | TYPE: Onsite

Quick Summary

The Quality Assurance Manager is responsible for developing, implementing, and maintaining the Quality Management System (QMS) to ensure compliance with ISO standards, customer requirements, and internal processes. This role leads quality initiatives and drives continuous improvement across the organization.

KEY RESPONSIBILITIES:

• Develop and maintain the site Quality Management System (QMS)
• Ensure compliance with ISO 9001 and customer/regulatory requirements
• Lead internal and external audits and corrective action processes
• Manage Non-Conformance (NCR) and CAPA programs
• Oversee inspection criteria, documentation, and calibration systems
• Train teams on quality processes and standards
• Partner cross-functionally with operations and engineering
• Analyze quality data and implement process improvements
  
  

REQUIREMENTS:

• Degree in Business, Manufacturing, engineering, Quality, or related field preferred
• 5+ years’ experience in a quality discipline or experience with quality systems preferred
• 5+ years’ experience in manufacturing industry required
• Experience with audits, CAPA, and continuous improvement tools
• Leadership experience managing teams or programs
• Ability to read and interpret technical drawings
• Strong knowledge of ISO 9001 standards
• ERP experience (Mie Trak a plus)
  
  

WORK AUTHORIZATION WORDING

Must meet ITAR U.S. Person requirements – The company maintains International Traffic in Arms Regulations (ITAR) compliant operations in United States based facilities. This position is subject to ITAR which requires U.S. Person status. ITAR defines U.S. Person as U.S. Citizens, lawful permanent residents, or foreign nationals granted refugee or asylee status.