MedTech Validation Engineer: Quality & Process Improvement

24-Hour HR Process Outsourcing, Inc.; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

24-Hour HR Process Outsourcing, Inc. is looking for an experienced professional in Irvine, California, to conduct gap analyses and optimize manufacturing processes. This role involves identifying errors in documentation and working closely with R&D while investigating product quality and compliance issues within the medical device industry.

The ideal candidate has at least 6 years of experience, a Bachelor's degree, and expertise in developing SOPs. Responsibilities include maintaining risk management files and creating training materials for production.

Qualifications

• Bachelor's degree required.
• Minimum of 6 years of experience.
• Minimum of 3 years of experience in the medical device industry.
• Experience in writing, creating, and developing SOPs.
• Familiarity with Gage R&R and Risk Analysis Gage R&R.
• Ability to compose protocol reports.

Responsibilities

• Conduct gap analysis and identify errors in documentation.
• Investigate manufacturing product quality and compliance issues.
• Optimize manufacturing processes using engineering methods.
• Develop and maintain risk management files.
• Create training and documentation materials for production.

Skills

SIX Sigma and LEAN methods

Gage R&R

Risk Analysis Gage R&R

Problem-solving

Education

Bachelor's degree

Tools

Technical documentation tools

Job description

24-Hour HR Process Outsourcing, Inc. is looking for an experienced professional in Irvine, California, to conduct gap analyses and optimize manufacturing processes. This role involves identifying errors in documentation and working closely with R&D while investigating product quality and compliance issues within the medical device industry.

The ideal candidate has at least 6 years of experience, a Bachelor's degree, and expertise in developing SOPs. Responsibilities include maintaining risk management files and creating training materials for production.