More jobs:
Quality Engineer
Job in
Irvine, Orange County, California, 92604, USA
Listed on 2026-01-10
Listing for:
Actalent
Full Time
position Listed on 2026-01-10
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Location:
Irvine, CA
Employment Type:
12-Month Contract
For immediate consideration, please apply directly to this job posting AND email me at biacosta with the following:
1) word copy of resume
2) 2-3 professional references
3) 4-5 brief bullet points highlighting technical qualifications
About the Role
We are seeking a detail-oriented Quality Engineer to lead quality operations projects and drive continuous improvement initiatives within a dynamic manufacturing environment. This role is critical in ensuring compliance with regulatory standards and maintaining the highest level of product quality for innovative medical solutions that improve patient care and safety.
As a Quality Engineer, you will manage corrective and preventive actions (CCR's), collaborate with cross-functional teams, and contribute to process improvement efforts. You'll play a key role in risk mitigation, technical documentation, and supporting remediation projects that strengthen operational excellence.
About the Company
A global leader in developing and manufacturing advanced medical products and services that address critical healthcare challenges, including opioid abuse prevention, hospital-acquired malnutrition, and hazardous drug exposure. Our mission is to improve patient outcomes and enhance safety across healthcare settings. With a strong commitment to innovation, quality, and compliance, we foster a collaborative environment where professionals can make a meaningful impact.
Our team combines technical expertise with a passion for improving lives, delivering solutions trusted by healthcare providers worldwide.
Responsibilities
+ Lead quality operations projects and manage corrective and preventive actions (CCR's).
+ Collaborate with quality operations management on remediation and improvement initiatives.
+ Write technical assessments summarizing quality-related gaps and corrective actions.
+ Work closely with product design, product management, and production teams to identify and mitigate risks.
+ Facilitate process improvement and product teams.
+ Prepare and submit technical documentation through change control and CAPA systems.
Essential Skills
+ Proficiency in quality engineering and assurance principles.
+
Experience with root cause analysis and audits.
+ Familiarity with medical devices and ISO standards.
+ Expertise in non-conformances, investigations, and CAPA processes.
+ Knowledge of FDA regulations and risk mitigation strategies.
+ Strong technical writing skills and documentation experience.
Additional Qualifications
+ Bachelor's degree with 2+ years of relevant experience.
+ Proficiency in NCMR, product discrepancies, and change control systems.
Work Environment
This is an on-site role in a manufacturing setting where innovative medical products are developed and produced. You'll join a team of 64 professionals, including technicians responsible for raw materials and finished products. The position requires strong project management skills and involves reviewing drawings and procedures to ensure compliance and quality standards.
Ready to make an impact? Apply today and join a team dedicated to advancing healthcare through innovation and quality.
Job Type & Location
This is a Contract position based out of Irvine, CA.
Pay and Benefits
The pay range for this position is $40.00 - $55.00/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 Jan 21, 2026.
About…
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