Quality Engineer II

Job Title: Quality Engineer II

Job Description

We are seeking a dedicated Quality Engineer II to join our team, where you will play a pivotal role in ensuring the quality performance of our products and processes. This position requires a proactive approach to problem-solving, as you will work closely with operations, business functions, and cross-functional teams to address quality issues and improve manufacturing processes.

Responsibilities

• Collaborate with operations, business functions, and cross-functional teams to ensure quality performance of products and processes.
• Engage with customers, sales, marketing, and field personnel to address top quality issues.
• Approve NC/CAPA and develop proficiency in problem-solving and root-cause analysis.
• Contribute to the development and improvement of manufacturing processes for existing products.
• Review change management activities and maintain KPIs for monitoring process and product quality.
• Perform analysis, interpret trends, and take necessary action based on KPI data.
• Execute and analyze complaints and product field actions.
• Advocate for Human Factor practices and develop familiarity with Human Factor identification, reduction, and mitigation.
• Develop an understanding of risk management practices and optimization of inspection methods and sampling.
• Gain proficiency in statistical methods and their application.
• Participate in internal audits, providing effective narrative and description of expertise topics.
• Assist in external audit preparation and build confidence and proficiency in interactions.
• Assist in the development and review of process and equipment validation/qualification.
• Support manufacturing transfers to other plants/facilities and execute quality activities.
• Initiate internal containment and support ship and product holds for potential product escapes.

Essential Skills

• Experience in quality engineering, quality assurance, supplier quality, production quality, and design quality.
• Familiarity with ISO standards and quality audits.
• Understanding of US and International Medical Device Regulations.
• Strong communication, project management, and influencing skills.
• Ability to manage multiple tasks simultaneously and represent the quality function in project teams.
• Strong interpersonal, written, and oral communication skills.
• Excellent critical thinking and problem-solving skills.
• Demonstrated ability to complete projects in a matrix organization and work independently as well as in cross-functional teams.
• Computer literacy.

Additional Skills & Qualifications

• Previous industry experience is desired.
• Experience in interacting with regulatory agencies such as FDA, MoH, and TUV is desired.
• Familiarity with GDP and GMP is desired.
• Knowledge of quality concepts such as risk management, CAPA, audits, and statistics.

Work Environment

This position is located onsite in Irvine, CA. We offer a supportive work environment where you will have the opportunity to develop your skills and contribute to impactful projects. You will enjoy 2 weeks of PTO and 10 paid holidays, providing a balanced work-life schedule.

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

The pay range for this position is $55.00 - $58.00/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 Jun 12, 2026.

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

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $55 - $58