Senior Quality Engineer - Medical Device NPD & Validation

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

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