Experience:

• Quality Assurance (evaluation, inspections, testing).: 5 years (Required)
• Root Cause Analysis (RCA): 3 years (Required)
• data-driven statistical analysis: 3 years (Required

• The Associate II, Quality Assurance Engineering is primarily responsible for developing and maintaining quality evaluation and control systems, conducting inspections and tests, and performing root cause analysis to ensure reliability standards. You will apply advanced technical knowledge and problem-solving skills. Specifics include:
• Autonomously leads investigations into production and customer-facing quality issues of medium complexity to identify root cause, implement corrective and preventative actions, and monitor effectiveness.
• Demonstrates intermediate understanding and application of role-specific technical and Quality skills and serves as a Subject Matter Expert (SME) for a product line.
• Develops cross-functional relationships to successfully influence behavior within a team or project.
• Monitors and analyzes global product performance using a data-driven statistical analysis and risk-based approaches.
• Effectively communicates (written and verbal) complex technical problems and solutions to a variety of audiences within the organization.
• Ensures compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices. Supports internal/external audits.
  Job Type: Contract
  Pay: $30.02 - $45.77 per hour

Application Question(s):

• Do you have knowledge of FDA regulations, ISO 13485, and other medical device regulatory standards ?

Experience:

• Quality Assurance (evaluation, inspections, testing).: 5 years (Required)
• Root Cause Analysis (RCA): 3 years (Required)
• data-driven statistical analysis: 3 years (Required)

Ability to Commute:

• Lake Forest, CA 92610 (Required)

Work Location: In perso