Quality Engineer II
Job in
Irvine, Orange County, California, 92604, USA
Listed on 2026-08-13
Listing for:
Astrix Technology
Full Time
position Listed on 2026-08-13
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
* Manufacturing
Irvine, California, US
+ Added - 10/08/2026
Pay Rate Low: 40.00 | Pay Rate High: 44.00
Exciting Quality Engineer II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in Surgical and Vision Care
** Quality Engineer II*
* *
* Location:
** Irvine, CA (Onsite)
*
* Contract:
** 12 month Contract with extension or conversion potential
** Benefits** :
Medical, Dental, Holiday, PTO 401K matching
** Pay:
** doe
** Quality Engineer - Medical Devices*
* Provide hands-on quality engineering support for new product development and design changes for instrumentation products. Partner with R&D, Regulatory, and cross-functional teams throughout the product development lifecycle.
*
* Key Responsibilities:
*
* + Support design controls, risk management, verification/validation, change control, and product transfer.
+ Review and approve design control, risk management, V&V, and development documentation.
+ Provide quality guidance and risk-based decision support to development teams.
+ Assess product and process changes for quality and regulatory impact.
+ Support deviation investigations, root cause analysis, and CAPA activities.
+ Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.
*
* Minimum Qualifications:
*
* + Bachelor's degree in Engineering, Life Sciences, or related technical field.
+ 2+ years of Quality Engineering experience in the medical device industry.
+ Experience supporting instrumentation or electromechanical product development in an ISO 13485 environment.
+
Experience with design controls, risk management, change control, and V&V.
+ Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.
+ Strong communication, collaboration, and independent problem-solving skills.
** Preferred:*
* +
Experience with statistical methods and V&V study design.
+ Knowledge of IEC 60601 and other applicable product/safety standards.
+ ASQ CQE or Six Sigma certification.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
Work Authorization Requirement
Candidates must be authorized to work in the United States on a permanent basis.
Sponsorship (including H-1B, OPT, CPT, etc.) is not available for this role now or in the future.
INDBH
LI-RL1
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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