Senior Quality Engineer

Katalyst CRO; Waukesha (WI); On-site; USD 85,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking a Senior Quality Engineer in Wisconsin to support MDR remediation, validation, and risk management for regulated medical device products. You will lead quality activities across product families, coordinate with Manufacturing, Quality, and Engineering, and drive change controls and documentation updates.

The role requires 4+ years in medical device quality, strong knowledge of MDR/820, ISO standards, and experience with PFMEAs, Control Plans, and testing validation.

Qualifications

• MDR remediation experience is preferred.
• 4+ years of relevant experience in medical device quality.
• Knowledge of FDA 21 CFR Part 820 and EU MDR.
• Experience with ISO 13485, ISO 14971, IEC 60601.
• Experience with change control and medical device quality systems.
• DOE/Minitab experience and CSV.
• SOP development and documentation experience.
• Agile PLM familiarity.
• Packaging validation and fit testing.

Responsibilities

• Support MDR remediation and manufacturing quality assurance activities.
• Develop and maintain PFMEAs, Control Plans, and risk management documentation.
• Conduct First Article Inspections (FAIs), dimensional verification, and packaging evaluations.
• Perform process validation activities including IQ, OQ, PQ, and test method validations.
• Conduct production floor assessments and process observations to support risk evaluations.
• Collaborate with Manufacturing, Quality, Warehouse, Planning, and Product Engineering teams.
• Review and approve manufacturing change orders and MDR-related updates.
• Support labeling verification, packaging testing, and technical documentation updates.
• Maintain documentation and change records within Agile PLM.
• Process validation and test method validation experience.
• PFMEA, Control Plan, and risk management expertise.
• Experience with FAIs, dimensional verification, and manufacturing changes.
• Knowledge of FDA 21 CFR Part 820 and EU MDR (2017/745).
• Familiarity with ISO 13485, ISO 14971, and IEC 60601.
• Experience with change control and medical device quality systems.

Skills

Quality assurance

MDR remediation

Risk management

Process validation

FAI

Dimensional verification

Regulatory compliance

Agile PLM

DOE/Minitab

SOP development

Packaging validation

Education

Bachelor's degree in Engineering

Tools

Agile PLM

DOE/Minitab

CSV knowledge

Job description

Summary

Seeking a Senior Quality Engineer with strong MDR remediation and medical device manufacturing quality experience to support compliance, validation, and risk management activities for regulated product families.

Roles & Responsibilities

• Support MDR remediation and manufacturing quality assurance activities
• Develop and maintain PFMEAs, Control Plans, and risk management documentation
• Conduct First Article Inspections (FAIs), dimensional verification, and packaging evaluations
• Perform process validation activities including IQ, OQ, PQ, and test method validations
• Conduct production floor assessments and process observations to support risk evaluations
• Collaborate with Manufacturing, Quality, Warehouse, Planning, and Product Engineering teams
• Review and approve manufacturing change orders and MDR-related updates
• Support labeling verification, packaging testing, and technical documentation updates
• Maintain documentation and change records within Agile PLM
• Process validation and test method validation experience
• PFMEA, Control Plan, and risk management expertise
• Experience with FAIs, dimensional verification, and manufacturing changes
• Knowledge of FDA 21 CFR Part 820 and EU MDR (2017/745)
• Familiarity with ISO 13485, ISO 14971, and IEC 60601
• Experience with change control and medical device quality systems

Education & Experience

• Bachelor's degree in Engineering or related discipline
• 4+ years of relevant experience (MDR experience highly preferred)
• DOE/Minitab experience
• Computer System Validation (CSV)
• SOP development
• Agile PLM experience
• Packaging validation and fit testing