Quality Engineer

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

Summary
New Product Development project or legacy product engaged in the development or sustenance of Pharmaceutical Electrophysiology medical device products. Performs ongoing execution of and provides guidance to good manufacturing practices, compliance to internal and external policies and other applicable standards.

• Provides product team support for multitude of new product development activities (e.g. engineering testing, design and process characterization, and other V&V activities)
• Assists in conducting Quality Assurance documentation reviews and audits as needed
• Support execution of risk management activities
• Support development and execution of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ)
• Utilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)
• Assists in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed
• Supports handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Collaborate with cross-functional teams to achieve project team goals and objectives

Summary

New Product Development project or legacy product engaged in the development or sustenance of Pharmaceutical Electrophysiology medical device products. Performs ongoing execution of and provides guidance to good manufacturing practices, compliance to internal and external policies and other applicable standards.

Roles & Responsibilities

• Provides product team support for multitude of new product development activities (e.g. engineering testing, design and process characterization, and other V&V activities)
• Assists in conducting Quality Assurance documentation reviews and audits as needed
• Support execution of risk management activities
• Support development and execution of relevant process development and validation activities (e.g. IQ/OQ/TMV/APQ)
• Utilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)
• Assists in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed
• Supports handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Collaborate with cross-functional teams to achieve project team goals and objectives

Education & Experience:

• A minimum of a bachelor's degree required (preferably in Engineering or related technical field); or a minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• Ability to develop and implement Quality standards
• Thorough knowledge of Quality systems and processes, including GMP and QSR requirements for medical devices
• Knowledge of new product development design controls, and verification and validation (V&V) tools and methodologies
• Demonstrated problem solving skills
• Competent in using basic documentation applications such as MS Office (Word, Excel, Powerpoint, Outlook), Adobe PDF, etc.
• Ability to multi-task and manage multiple assignments in a timely manner
• Good verbal and written communication skills
• Strong analytical skills
• Ability to apply project management skills to ensure fulfillment of new product development requirements
• Experience working in both an FDA and European regulatory environment
• Expertise in NPD (New Product Development) process and Design/Process Validation
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools
• Six Sigma Green/Black Belt Certified
• Knowledge of GD&T (Geometric Dimensioning and Tolerancing)
• Knowledge of statistical analysis tools such as Minitab is a plus