Quality Engineer

CyberX Info System; Minneapolis (MN); On-site; USD 110,000 - 135,000; Full time

Job summary

CyberX Info System seeks a Senior Quality Engineer to lead quality activities across a manufacturing value stream for Class II and Class III ENT medical devices. You will partner with Manufacturing, R&D, Regulatory, and Validation teams to drive continuous improvement, containment, and compliance.

The role focuses on CAPAs, NCMRs, sterilization validation, and risk management, with visibility across the organization and opportunities to influence product quality and business strategy.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years of Quality Engineering in the medical device industry.
• Experience with Class II and/or Class III medical devices.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and risk management principles.
• Demonstrated experience owning CAPAs, NCMRs, root cause investigations, and manufacturing quality initiatives.
• Experience supporting sterilization validation activities, including EO and Gamma sterilization.

Responsibilities

• Own quality activities for an assigned product value stream, ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
• Lead the Quality Engineering function for legacy product lines, driving continuous improvement and manufacturing support.
• Lead and facilitate root cause investigations using structured problem solving methodologies.
• Own Nonconforming Material Reports (NCMRs) and CAPAs from initiation through verification and closure.
• Partner with Manufacturing, Operations, R&D, Supply Chain, Regulatory Affairs, and Validation teams to resolve quality issues and improve processes.
• Develop, revise, and maintain SOPs, work instructions, quality plans, and related documentation.
• Ensure alignment of quality procedures with regulatory requirements and best practices.
• Author and review sterilization documentation including EO and Gamma sterilization validation.
• Analyze quality metrics and manufacturing data to identify trends and preventive actions.
• Support audits and regulatory inspections and supplier quality initiatives.
• Drive risk reduction using FMEA, statistical analysis, and process capability studies.
• Mentor junior engineers and mature the Quality organization.

Skills

CAPA ownership

Root cause investigations

Statistical analysis

Process capability studies

Cross-functional collaboration

Documentation writing

Leadership

Education

Bachelor's degree in Engineering or related technical discipline

Job description

Our client is seeking a Senior Quality Engineer to support the development, manufacturing, and continuous improvement of Class II and Class III ENT medical devices. This is a highly visible role with ownership of an entire manufacturing value stream, serving as the primary quality partner for cross functional teams throughout the product lifecycle.

The ideal candidate is a hands on quality professional with strong experience in regulated medical device manufacturing, process improvement, root cause investigations, and sterilization validation. This position offers significant growth potential and the opportunity to influence product quality, operational excellence, and business strategy.

Key Responsibilities

• Own quality activities for an assigned product value stream, ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
• Serve as the Quality Engineering lead for legacy product lines, driving continuous improvement, product quality, and manufacturing support.
• Lead and facilitate root cause investigations using structured problem solving methodologies.
• Own Nonconforming Material Reports (NCMRs) and Corrective and Preventive Actions (CAPAs) from initiation through effectiveness verification and closure.
• Partner with Manufacturing, Operations, R&D, Supply Chain, Regulatory Affairs, and Validation teams to resolve quality issues and improve processes.
• Develop, revise, and maintain Standard Operating Procedures (SOPs), work instructions, quality plans, and related documentation.
• Ensure alignment of quality procedures with regulatory requirements and operational best practices.
• Author and review sterilization documentation, including:
• Annual sterilization review reports
• Bioburden testing summary reports
• Gamma sterilization testing summary reports
• Ethylene Oxide (EO) sterilization validation and routine processing documentation
• Analyze quality metrics and manufacturing data to identify trends and implement preventive actions.
• Support internal and external audits, customer audits, supplier quality initiatives, and regulatory inspections.
• Drive risk reduction activities using tools such as FMEA, statistical analysis, and process capability studies.
• Mentor junior engineers and contribute to the continued maturity of the Quality organization.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5 plus years of Quality Engineering experience within the medical device industry.
• Experience supporting Class II and/or Class III medical devices.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and risk management principles.
• Demonstrated experience owning CAPAs, NCMRs, root cause investigations, and manufacturing quality initiatives.
• Experience supporting sterilization validation activities, including EO and Gamma sterilization.
• Knowledge of bioburden testing, sterilization validation protocols, and annual sterilization review requirements.
• Experience writing technical reports and quality documentation.
• Strong understanding of manufacturing processes, validation, statistical analysis, and continuous improvement methodologies.
• Excellent communication, leadership, and cross functional collaboration skills.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Experience with Design Controls, Process Validation, and Risk Management.
• Lean Six Sigma certification or equivalent continuous improvement experience.