"Alerted.org

Hiring an immediate Quality Engineer (Trackwise) in Irvine CA!

For Immediate consideration please apply to this posting and email your resume to [email protected]

Job Description

We are seeking a dedicated Quality Engineer specialized in Trackwise to ensure compliance with CAPA processes and procedures. The role involves reviewing and approving NC and CAPAs, ensuring attention to detail, completeness of actions and records, accuracy, effectiveness, and timeliness. You will liaise with relevant functional groups to facilitate and guide teams through all stages of the NC/CAPA process.

Responsibilities

+ Ensure rigorous compliance to the eCAPA system content, maintaining a live record with all relevant evidence attached promptly.

+ Build expertise in facilitating NC and CAPA teams with problem-solving techniques and promote its development.

+ Serve as an eCAPA super-user with high proficiency in NC/CAPA procedure requirements.

+ Execute the NC/CAPA review board forums and monitor site NC/CAPA KPIs, ensuring compliance with global requirements.

+ 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

+ Strong communication and influencing skills with the ability to manage multiple tasks simultaneously.

+ Strong interpersonal skills and the ability to work independently.

+ Proficient in Trackwise software and computer literacy, including Microsoft Word, Excel, and PowerPoint.

+ In-depth understanding of NCR, CAPA processes, and regulatory requirements for medical devices.

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.

+ Experience in interacting with regulatory agencies such as FDA, MoH, and TUV.

+ ASQ Certified Quality Engineer (CQE) or equivalent preferred.

Work Environment

The role offers 2 weeks of PTO and 10 holidays. It requires comfort working in compliance-risk situations and provides opportunities to develop problem-solving and analytical thinking skills. The work environment encourages strong communication, collaboration, and independent work, with a focus on quality systems, audits, and management review.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Oct 29, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.