Quality Engineer (TrackWise)

Responsibilities

• Ensure compliance to CAPA processes and procedures.
• Review and approve NC and CAPAs for completeness, accuracy, effectivity, and timeliness.
• Liaise with relevant functional groups and guide teams through all stages of the NC/CAPA process.
• Maintain a live record with all relevant evidence attached in a timely manner in the eCAPA system.
• Facilitate NC and CAPA teams in the application of problem-solving techniques and promote their development.
• Serve as an eCAPA super-user and ensure proficiency in NC/CAPA procedure requirements.
• Execute NC/CAPA review board forums.
• Monitor site NC/CAPA KPIs and report updates in support of quality and business review forums.
• Ensure compliance to global requirements and metrics.
• Identify continuous improvement and collaboration opportunities.
• Engage in cross-site and corporate project teams in NC/CAPA area of expertise.
• Coordinate preparation, participation, and follow-up for internal, corporate, and third party audit activities.

Essential Skills

• Experience in quality engineering within the medical device industry.
• Proficiency in TrackWise software.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• In-depth understanding of NCR, CAPA processes, and regulatory requirements for medical devices.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Ability to support Quality Systems (audits, management review, quality planning, etc.).
• Computer literacy, including Microsoft Word, Excel, and PowerPoint.

Additional Skills & Qualifications

• Bachelor's degree in Engineering, Quality Management, or a related field.
• Minimum of 3-5 years of experience in quality engineering within the medical device industry.
• ASQ Certified Quality Engineer (CQE) or equivalent preferred.
• Strong communication and influencing skills.
• Ability to manage multiple tasks simultaneously.
• Strong interpersonal skills.
• Ability to develop problem-solving skills.
• Analytical thinking skills.
• Ability to work independently.
• Comfort working in a compliance-risk situation.

Work Environment

This position offers a work environment that includes two weeks of PTO and 10 holidays. The role involves cross-site and corporate project teams, requiring interaction with regulatory agencies and participation in audit activities. The workspace adheres to high compliance standards and utilizes the latest technologies to maintain quality and regulatory requirements.

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 May 8, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $57