Quality Assurance Lead

Mach10 Solutions; Crystal Lake (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Mach10 Solutions is seeking a Quality Assurance Lead to oversee inspection personnel, enforce ISO 13485 compliance, and drive continuous improvement in production quality. The role will function as a key technical resource within a fast-moving manufacturing environment.

You will coordinate with cross-functional teams, mentor QA staff, and lead efforts to optimize production quality processes from planning through audits, in Crystal Lake, Illinois.

Qualifications

• Minimum of 2 years of experience supervising a QA lab within an ISO 13485 regulated environment.
• Proficiency in MS Office Suite (Excel, Word, PowerPoint, Outlook).
• Strong technical aptitude with Statistical Process Control (SPC) software.
• Exceptional organizational and communication skills to facilitate knowledge sharing.
• Ability to pass pre-employment reading and measurement assessments.

Responsibilities

• Direct and mentor quality inspection staff to ensure consistent performance and professional development.
• Enforce ISO 13485 compliance across all production and laboratory activities to maintain high-quality output.
• Streamline quality procedures and documentation to improve operational efficiency and audit readiness.
• Coordinate with cross-functional teams to resolve complex quality issues and align on production priorities.
• Manage shift staffing and training schedules to ensure seamless coverage and skill competency.
• Utilize SPC software to monitor process stability and drive continuous improvement initiatives.
• Act as a primary point of contact for quality-related inquiries and provide leadership support to the QA management team.

Skills

2+ years QA supervision

MS Office proficiency

SPC software

Organizational & communication skills

Reading & measurement assessments

Education

High school diploma or equivalent

Associate degree or Bachelor degree preferred

Tools

MS Office Suite

SPC software

ERP systems

Job description

As a Quality Assurance Lead, you will spearhead our quality initiatives by overseeing inspection personnel and ensuring rigorous adherence to regulatory standards. You will play a pivotal role in optimizing production quality processes and serving as a key technical resource for the department.

About the Role

As a Quality Assurance Lead, you will spearhead our quality initiatives by overseeing inspection personnel and ensuring rigorous adherence to regulatory standards. You will play a pivotal role in optimizing production quality processes and serving as a key technical resource for the department.

Responsibilities

• Direct and mentor quality inspection staff to ensure consistent performance and professional development.
• Enforce ISO 13485 compliance across all production and laboratory activities to maintain high-quality output.
• Streamline quality procedures and documentation to improve operational efficiency and audit readiness.
• Coordinate with cross-functional teams to resolve complex quality issues and align on production priorities.
• Manage shift staffing and training schedules to ensure seamless coverage and skill competency.
• Utilize SPC software to monitor process stability and drive continuous improvement initiatives.
• Act as a primary point of contact for quality-related inquiries and provide leadership support to the QA management team.

Required Skills

• High school diploma or equivalent required; Associate or Bachelor degree preferred.
• Minimum of 2 years of experience supervising a QA lab within an ISO 13485 regulated environment.
• Demonstrated proficiency in MS Office Suite (Excel, Word, PowerPoint, Outlook).
• Strong technical aptitude with Statistical Process Control (SPC) software.
• Exceptional organizational and communication skills to facilitate knowledge sharing.
• Ability to pass pre-employment reading and measurement assessments.

Preferred Skills

• Prior experience within the flexible packaging industry.
• Hands‑on experience with ERP systems for data management.
• Proven track record of managing quality workflows in a medical device or pharmaceutical setting.

Our Story

Founded in Montana, Mach10 Solutions has rapidly expanded to provide premium fabrication and engineering services across the United States. Our journey began with a simple mission: deliver precision engineering solutions at unprecedented speeds.

Today, we leverage cutting‑edge technology and exceptional talent to provide manufacturing services that consistently exceed expectations. With a focus on quality, speed and innovation, we’ve become the trusted partner for companies seeking competitive advantages through superior fabrication and design.

At Mach10, we don’t just build components – we forge lasting partnerships through reliability, expertise, and our commitment to pushing the boundaries of what’s possible.

Our Services

Precision Fabrication

State‑of‑the‑art manufacturing delivering tight‑tolerance components with uncompromising accuracy.

Design & Drafting

Comprehensive CAD modeling, documentation and DFM optimization to ensure flawless execution.

Field Services

Nationwide on‑site technical support, installation and maintenance from highly trained experts.

Quality Assurance

Rigorous inspection protocols guarantee every component meets or exceeds industry standards.

Project Management

End‑to‑end project coordination with clear communication and on‑time delivery.

Rapid Prototyping

Accelerated development cycles turn concepts into functional prototypes at record speed.

Why Choose Mach10

17+

States Served

64+

Projects Completed

98.2%

Quality Rating

24/7

Technical Support

Recent Projects

Automotive Prototype

Rapid‑turn aluminum prototype trimmed production timeline by 6weeks.

Fully integrated robotic welding cell installed and commissioned on‑site.