Senior Quality Engineer

CyberX Info System; Eagan (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

CyberX Info System is seeking a Senior Quality Engineer to own quality activities across a manufacturing value stream for Class II and III ENT medical devices, ensuring FDA and ISO 13485 compliance. You will lead root cause investigations, CAPAs, NCMRs, and drive continuous improvement with cross-functional teams.

The role emphasizes sterilization validation activities (EO and Gamma), annual reviews, and robust documentation, with mentorship to growing Quality engineers and close collaboration

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ 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.

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.

Skills

Quality engineering

Regulatory compliance

Root cause investigations

CAPA management

Sterilization validation

Process improvement

Cross-functional collaboration

FMEA

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.