QA Lead: ISO 13485 Champion & Process Optimizer

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

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.