Quality Engineer, Medical Devices – NPD & Compliance

Katalyst CRO; Irvine (CA); On-site; USD 90,000 - 125,000; Full time

Job summary

Katalyst CRO seeks a Quality Assurance professional to support new product development and sustainment of electrophysiology medical devices. You will ensure GMP/QSR compliance, assist in V&V activities, and guide QA documentation reviews while collaborating with cross-functional teams.

The role requires a bachelor’s degree in engineering or related field (or 2 years in a regulated setting), knowledge of GMP/QSR, and strong problem-solving skills.

Qualifications

• A bachelor's degree in Engineering or related technical field is required; or 2 years in quality/manufacturing/R&D in a medical device or regulated industry.
• Knowledge of GMP and QSR requirements for medical devices.
• Familiarity with NPD process, design/process validation, and V&V tools.
• Demonstrated problem-solving skills and strong documentation abilities.
• Ability to multi-task and communicate effectively across teams.
• Experience in FDA and European regulatory environments is preferred.
• ASQ certification or Six Sigma experience is a plus.

Responsibilities

• Support development and execution of process development and validation activities (IQ/OQ/TMV/APQ).
• Assist in QA documentation reviews and audits as needed.
• Provide guidance on GMP/GDP compliance and quality systems.
• Address product or process issues and investigate customer complaints.
• Collaborate with cross-functional teams to meet project goals.

Skills

Quality systems

GMP

QSR

NPD process

Design/Process Validation

V&V tools

Problem solving

MS Office

Communication

Analytical skills

Project management

FDA and European regulations

Education

Bachelor's degree in Engineering or related field

2 years in quality/manufacturing/R&D in a medical device or regulated industry

Tools

Minitab

MS Office

Adobe PDF

Job description

Katalyst CRO seeks a Quality Assurance professional to support new product development and sustainment of electrophysiology medical devices. You will ensure GMP/QSR compliance, assist in V&V activities, and guide QA documentation reviews while collaborating with cross-functional teams.

The role requires a bachelor’s degree in engineering or related field (or 2 years in a regulated setting), knowledge of GMP/QSR, and strong problem-solving skills.