Sr Quality Engineer

Katalyst CRO; Irvine (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Sr Quality Engineer to support product development and cleanroom build activities in a medical device environment. You will ensure compliance with quality systems and regulatory standards, update risk management and design control files, and lead test method validations and verification activities across multi-site transfers.

The role requires experience in NPD, DA, ISO 13485, and strong cross-functional collaboration with R&D, manufacturing, regulatory, and clinical

Qualifications

• Bachelor's degree in Engineering or Scientific field with 4+ years' experience, or Master's with 3+ years.
• Experience in NPD, Design Assurance (DA), and Quality Engineering preferred.
• Understanding of medical device operations/manufacturing processes; medical device exp. preferred.
• ISO 13485 knowledge and quality principles understanding.

Responsibilities

• Support product development and cleanroom build activities in a medical device environment.
• Ensure compliance with quality systems and regulatory standards.
• Update risk management and design control files, maintain quality documentation.
• Develop and execute test method validations and qualification plans.
• Support design verification and facilitate process validation and multi-site transfer.
• Collaborate with R&D, manufacturing, regulatory, clinical, and marketing teams.
• Perform quality engineering activities related to product development and ongoing cleanroom build support.
• Other duties assigned by leadership.

Skills

Quality engineering

NPD support

Risk management

Design assurance

Regulatory standards

Test method validation

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering or Scientific field

Master's degree in Engineering or Scientific field

Tools

Minitab

Job description

• 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.
• 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

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.
• 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

Roles & Responsibilities:

• 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.
• 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