Quality Assurance Manager - 253580

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

We are seeking a motivated and driven Quality Assurance Manager to lead quality initiatives, system improvements, and failure analysis across our product lines. In this role, you will be responsible for identifying failure modes, conducting root cause analysis, and implementing Standard Operating Procedures (SOPs) and process improvements to mitigate quality risks.

Key Responsibilities:

Quality Systems & SOP Management

• Procedure Development: Write, maintain, and enforce SOPs and processes for documenting product requirements, specifications, verifications, and validations in compliance with ISO requirements (ISO 13485) and FDA regulations.

Failure Analysis & Process Improvement

• Root Cause & Trend Analysis: Identify failure modes, track failure trends, and perform thorough root cause analyses to implement corrective and preventive actions.
• Lean Integration: Promote Lean Manufacturing principles and Total Cost of Ownership concepts, focusing on value creation, waste elimination, and process efficiency.

Supplier Quality & Material Inspection

• Material & Product Inspection: Inspect incoming materials, in-process components, and finished products; manage non-conforming materials and process deviations.

Cross-Functional Collaboration & Project Leadership

• Collaborative Problem Solving: Partners with engineering, manufacturing, and supply chain teams to engineer robust design and manufacturing solutions.