Sr Quality Engineer

Katalyst CRO; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Sr Quality Engineer to support product development and cleanroom build activities in California. The ideal candidate will ensure compliance with quality systems and regulatory standards while collaborating with cross-functional teams. Requirements include a Bachelor’s degree in Engineering or a related field with substantial experience in NPD and Quality Engineering. Strong problem-solving and documentation skills are essential, along with a good understanding of ISO 13485. This role offers an opportunity to contribute to medical device projects in a dynamic environment.

Qualifications

• 4+ years of experience with Bachelor's degree in Engineering or Scientific field, or 3+ years with Master's.
• Experience in product development, quality assurance, and/or related fields.
• Proficient understanding of medical device operations and/or manufacturing processes.

Responsibilities

• Perform Quality Engineering activities for product development.
• Ensure compliance with quality system and regulatory standards.
• Update risk management and design control files.

Skills

Experience in NPD

Design Assurance (DA)

Quality Engineering

Problem-solving skills

Documentation skills

Communication skills

Understanding of ISO 13485

Analytical skills

Education

Bachelor's degree in Engineering or Scientific field

Master's degree in Engineering or Scientific field

Tools

Statistical software (e.g., Minitab)

Job description

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