QA Manager: ISO 13485 | Root Cause, SOPs & Lean

Medix™; Minneapolis (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Medix seeks a motivated Quality Assurance Manager to lead quality initiatives across our product lines, drive system improvements, and perform failure analysis.

In this role you will identify failure modes, conduct root cause analysis, and implement SOPs to mitigate quality risks in compliance with ISO 13485 and FDA requirements. Collaborate with engineering, manufacturing, and supply chain to ensure robust design and compliant processes.

Qualifications

• Experience leading QA initiatives in healthcare/manufacturing
• Strong root-cause analysis and CAPA skills
• Proven ability to develop and enforce SOPs to meet regulatory standards

Responsibilities

• Lead Quality Systems & SOP management per ISO 13485 and FDA requirements
• Conduct root cause and trend analysis to drive corrective/preventive actions
• Promote Lean manufacturing principles to improve process efficiency
• Manage supplier quality and material inspection processes
• Collaborate with engineering, manufacturing and supply chain to deliver robust solutions

Skills

Root cause analysis

Lean manufacturing

Cross-functional collaboration

SOP development

Tools

ISO 13485

FDA regulations

Job description

Medix seeks a motivated Quality Assurance Manager to lead quality initiatives across our product lines, drive system improvements, and perform failure analysis.

In this role you will identify failure modes, conduct root cause analysis, and implement SOPs to mitigate quality risks in compliance with ISO 13485 and FDA requirements. Collaborate with engineering, manufacturing, and supply chain to ensure robust design and compliant processes.