Senior Quality Engineer

CyberX Info System; Minneapolis (MN); On-site; USD 120,000 - 160,000; Full time

Job summary

CyberX Info System is seeking a Senior Quality Engineer to lead quality activities across a manufacturing value stream for Class II and III ENT medical devices. The role partners with cross-functional teams to ensure regulatory compliance and drive continuous improvement.

The ideal candidate will own root cause investigations, CAPAs, NCMRs, sterilization validation, and quality documentation while mentoring junior engineers and shaping the Quality organization’s future.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years of Quality Engineering experience in medical devices.
• Experience with Class II/III medical devices and regulatory requirements.

Responsibilities

• Own quality activities for assigned product streams ensuring FDA/ISO 13485 compliance.
• Lead CAPAs and NCMRs from initiation through verification.
• Drive root cause investigations using structured problem solving.
• Develop and maintain SOPs, work instructions, and quality plans.
• Support internal and external audits and supplier quality initiatives.
• Mentor junior engineers and advance quality maturity.

Skills

Root cause analysis

Cross-functional leadership

Quality system ownership

Regulatory compliance

Education

Bachelor's degree in Engineering

Tools

FMEA

Statistical analysis

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.