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Sr Quality Engineer

Katalyst Healthcares & Life Sciences

Irvine, CA

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JOB DETAILS
SKILLS
Analysis Skills, Cleanroom, Communication Skills, Cross-Functional, Design Verification, Detail Oriented, Documentation, File Maintenance, ISO (International Organization for Standardization), Leadership, Maintain Compliance, Manufacturing Requirements, Manufacturing/Industrial Processes, Marketing, Medical Equipment, Minitab, Operations Processes, Problem Solving Skills, Process Validation, Product Development, Product Support, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Regulations, Research & Development (R&D), Risk Management, Statistics Software, Technical Writing, Test Plan/Schedule
LOCATION
Irvine, CA
POSTED
30 days ago
Job Summary:
  • The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.
  • The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.
Roles & Responsibilities:
  • Perform Quality Engineering activities related to product development and ongoing cleanroom build support
  • Ensure NPD processes comply with the quality system and applicable regulatory standards
  • Update risk management and design control files and maintain relevant quality documentation
  • Develop and execute test method validations and qualification plans
  • Support design verification and facilitate process validation and commercialization activities related to multi-site transfer
  • Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing
  • Other duties assigned by Leadership
Education & Experience:
  • Bachelor's degree in Engineering or Scientific field & 4+ years' experience OR Master's degree or equivalent in Engineering or Scientific field & 3+ years' experience
  • Strong preference for candidates with experience in NPD, Design Assurance (DA), and Quality Engineering
  • Proficient understanding of medical device operations and/or manufacturing processes; medical device experience strongly preferred
  • Relevant experience in product development, quality assurance, and/or related fields
  • Knowledge and understanding of Engineering and Quality principles, theories, and concepts
  • Understanding of ISO 13485
  • Experience developing, updating, and maintaining technical content of risk management files
  • Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus
  • Experience in test method development including validation and/or fixture development
  • Solid problem-solving, organizational, analytical, and critical thinking skills
  • Good documentation and communication skills with attention to detail
  • Ability to build productive working relationships and interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment

About the Company

K

Katalyst Healthcares & Life Sciences

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