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Senior Quality Engineer

Katalyst Healthcares & Life Sciences

waukesha, WI

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JOB DETAILS
SKILLS
Agile PLM / Oracle PLM (Product Lifecycle Management), Change Control, Change Requests/Orders, Code of Federal Regulations, Computer Systems, Documentation, FDA (Food and Drug Administration), Healthcare Quality, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Manufacturing, Medical Equipment, Minitab, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Product Engineering, Product Management, Product Planning, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Risk Analysis, Risk Management, Standard Operating Procedures (SOP), System Validation, Technical Writing, Testing, United States Department of Energy (DOE), Validation Testing, Warehousing
LOCATION
waukesha, WI
POSTED
30+ days ago
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

About the Company

K

Katalyst Healthcares & Life Sciences

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