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Association of Collegiate Conference and Events Directors-International; Beverly Hills (CA); On-site; USD 79,000 - 139,000; Full time

Job summary

A leading company in the medical device industry is seeking a Quality Engineer II to develop and maintain quality engineering methodologies. The role involves supporting new product development and ensuring compliance with FDA regulations. Candidates should have a Bachelor's in Industrial Engineering and a minimum of 2 years of experience in quality engineering practices.

Qualifications

• Minimum 2 years of professional experience in quality engineering.
• Experience with FDA regulations and ISO standards.

Responsibilities

• Develop and maintain quality engineering methodologies.
• Provide quality engineering support for product development.
• Implement product and process improvement initiatives.

Skills

Quality Engineering

Process Control

Six Sigma

Lean Manufacturing

Education

Bachelor's in Industrial Engineering

Job description

Beverly Hills, California, United States

(on-site)

Job Type: Full-Time

Min Experience: None

Job Function: Accounting/Finance

Description

Quality Engineer (Qual Eng) II: St. Jude Medical, an Abbott Labs Co., located in Sylmar, CA, seeks qualified Qual Eng II. Responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Qualifications:

• Bachelor's or foreign equivalent in Industrial Engineering or related engineering or technical field of study with a minimum of 2 years of professional experience.
• Experience in implementing assurances, process control, and Corrective & Preventive Action (CAPA) systems.
• Designing and conducting experiments (DOE) for process optimization and/or improvement, including protocol writing and reporting.
• Implementing various product and process improvement initiatives according to Six Sigma and Lean Manufacturing methodologies.
• Product Verification & Validation activities, including Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ).
• Ensuring compliance with U.S. FDA regulations and industry standards for medical device manufacturing, including 21 CFR 820, GMPs, ISO 13485, and ISO 14971.

This position is an Equal Opportunity Employer. Work hours are 40 hours per week. Salary ranges from $79,500 to $138,700 annually.

Resumes should be sent to: Abbott Laboratories, Elvia Salazar, 233 W. Wacker Dr., Floor 25, Dept. 32, Chicago, IL 60606. Please refer to ad code: SJM-0049-ES.