More jobs:
Quality Engineer II
Job in
Irvine, Orange County, California, 92604, USA
Listed on 2026-06-17
Listing for:
Actalent
Full Time
position Listed on 2026-06-17
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering, Process Engineer
Job Description & How to Apply Below
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.
Job Type & Location
This is a Contract position based out of Irvine, CA.
Pay and Benefits
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)
Workplace Type
This is a fully onsite position in Irvine,CA.
Final date to receive applications
This position is anticipated to close on Jun 12, 2026.
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