Quality Engineer II (Trackwise)

Quality Engineer (Trackwise)

The Quality Engineer will ensure compliance with CAPA processes and procedures, focusing on the review and approval of Non-Conformances (NC) and Corrective and Preventive Actions (CAPAs). The engineer will work collaboratively with relevant functional groups to facilitate and guide teams through all stages of the NC/CAPA process.

Responsibilities

• Ensure users provide necessary rigor to the eCAPA system content, maintaining a live record with all relevant evidence attached promptly.
• Build expertise in facilitating NC and CAPA teams through problem-solving techniques such as human error reduction, 4-D, 5 Why's, fishbone diagrams, and process mapping.
• Serve as a highly proficient NC/CAPA procedure expert and eCAPA super-user.
• Execute NC/CAPA review board forums.
• Monitor site NC/CAPA KPIs, including reporting requirements, and provide detailed updates for quality and business review forums.
• Ensure compliance with global requirements and achieve metrics.
• Identify continuous improvement and collaboration opportunities.
• Engage in cross-site and corporate project teams specializing in NC/CAPA.
• Coordinate preparation, participation, and follow-up for internal, corporate, and third-party audit activities.

Essential Skills

• Quality engineering experience in the medical device industry.
• Proficiency in Trackwise software.
• In-depth understanding of NCR, CAPA processes, and regulatory requirements for medical devices.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Ability to work independently and manage multiple tasks simultaneously.
• Computer literacy, including Microsoft Word, Excel, and PowerPoint.

Additional Skills & Qualifications

• Bachelor's degree in Engineering, Quality Management, or a related field.
• 3-5 years of experience in quality engineering within the medical device industry.
• Strong interpersonal skills.
• Exhibited analytical thinking skills.
• Comfortable working in a compliance-risk situation.
• ASQ Certified Quality Engineer (CQE) or equivalent preferred.

The position offers a professional setting with opportunities for cross-site and corporate collaboration. The role involves engaging in internal, corporate, and third-party audit activities. Employees enjoy 2 weeks of paid time off and 10 holidays annually.

This is a Contract position based out of Irvine, California.

The pay range for this position is $50.00 - $57.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Irvine, CA.

This position is anticipated to close on Oct 23, 2025.