Senior Quality Engineer

Katalyst CRO; Waukesha (WI); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a knowledgeable Senior Quality Engineer located in Waukesha, Wisconsin. The ideal candidate should have experience with MDR remediation and medical device manufacturing quality compliance. Responsibilities include supporting quality assurance activities, developing risk management documentation, and collaborating with various teams. A Bachelor’s degree in Engineering or related field along with 4+ years of relevant experience is required. Join us to impact the quality standards in regulated product families.

Qualifications

• Bachelor's degree in Engineering or related discipline required.
• 4+ years of relevant experience in quality engineering or MDR.
• Experience with process validation activities including IQ, OQ, PQ.

Responsibilities

• Support MDR remediation and manufacturing quality assurance activities.
• Develop and maintain PFMEAs, Control Plans, and risk management documentation.
• Collaborate with Manufacturing, Quality, Warehouse, Planning, and Product Engineering teams.

Skills

MDR remediation

Medical device manufacturing quality

Risk management

Process validation

FDA 21 CFR Part 820 knowledge

Knowledge of ISO 13485 and ISO 14971

Education

Bachelor's degree in Engineering or related discipline

4+ years of relevant experience

Tools

DOE

Minitab

Agile PLM

Computer System Validation (CSV)

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