Sr. Quality Engineer

24-Hour HR Process Outsourcing, Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

24-Hour HR Process Outsourcing, Inc. is seeking a skilled Quality Engineer in Irvine, California. The role involves applying engineering principles to resolve complex product quality and compliance issues in manufacturing.

Qualified candidates should have a Bachelor's degree and at least 8 years of experience, including 3 in the medical device industry. The position offers the chance to lead significant investigations and optimize quality processes.

Qualifications

• Minimum of 8 years of experience in quality engineering.
• Minimum of 3 years in the medical device industry.

Responsibilities

• Lead investigations of complex manufacturing quality issues.
• Manage execution of experiments and tests to validate products.
• Identify and optimize manufacturing processes using engineering methods.

Skills

Quality engineering principles

Leadership in investigations

Lean methods

Six Sigma methods

Education

Bachelor's degree

Job description

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities:

• Initiate and lead the investigation of highly complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports, based on engineering principles
• Drive the development and manage the execution of multiple, highly complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion
• Lead in the identification and ensure the optimization of highly 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 highly complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

Qualifications

Education and Experience:

• Bachelor's degree required
• Minimum of 8 years of experience
• Minimum of 3 years of experience in medical device industry

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