Validation Engineer

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

This is a gap analysis product line-decide where the gaps are and why, will be identifying the gaps. Many errors have been found in documentation and need to work closely with R&D. This project is very dynamic and changing. FDA will be coming on site need to make corrections.

Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk

Develop, update, and maintain technical content of risk management files

Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes

Qualifications

• Bachelor's degree required
• Minimum of 6 years of experience
• Minimum of 3 years of experience in medical device industry
• Must have written, created and developed SOPs
• Gage R&R experience, and Risk Analysis Gage R&R
• Compose protocol reports

Additional Information

All your information will be kept confidential according to EEO guidelines.