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Quality Engineering Manager
14 hours ago
Eaton Irvine, United StatesEaton's IS AER FMC division is currently seeking a Quality Engineering Manager. This position will be a part of Eaton's Aerospace group, specifically supporting the Irvine California facility. This facility has roughly 200 employees, with output in excess of $100M annually. · The ...
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Quality Engineer
1 week ago
TalentBurst, an Inc 5000 company Irvine, United StatesPosition: Quality Engineer I/II · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering ...
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Quality Engineer
1 week ago
Motion Recruitment Irvine, United StatesTitle: Engineer-1 (Quality) · Location: Irvine, CA · Duration: Contract · About the Client: · Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitorin ...
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Quality Engineer
6 days ago
Motion Recruitment Irvine, United StatesTitle: Engineer-2 (Quality) · Location: Irvine, CA · Duration: Contract · About the Client: · Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitorin ...
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Quality Engineer
3 days ago
TalentBurst, an Inc 5000 company Irvine, United StatesPosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1 · Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · Education and Experience: · Bachelor's degree in ...
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Quality Engineer
1 week ago
INTELLECTT INC Irvine, United StatesRole: Quality Engineer · Location: Irvine, CA · Duration: 06+ Months on W2 · Job Description: · Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective a ...
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Quality Engineer
4 hours ago
TalentBurst Irvine, United StatesPosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1 · Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · Education and Experience: · Bachelor's degree i ...
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Quality Engineer
12 hours ago
Cynet Systems Irvine, United StatesPay range: $30 to $36.00 · Job Description: · Qualifications:Planned, organize, and prioritize complaint investigation activities based on complaint closure and reportability timelines. · Perform analysis in No Product Return Evaluations by utilizing multiple data inputs inclu ...
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Quality Engineer
6 days ago
Motion Recruitment Irvine, United StatesTitle: Engineer-2 (Quality) · Location: Irvine, CA · Duration: Contract · About the Client: · Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitorin ...
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Quality Engineer
6 days ago
INTELLECTT INC Irvine, United Statespoistion-Quality Engineer · Location: · Irvine, CA · Duration: · 3 Months · Job Description · This position will be in THV Quality Engineering, Global Product Surveillance (GPS). · The GPS team is responsible for leading and performing critical engineering investigations on ...
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Quality Engineer
1 week ago
TalentBurst Irvine, United StatesPosition: Quality Engineer I/II · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical enginee ...
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Quality Engineer
1 week ago
Cynet Systems Irvine, United StatesPay range: $30 to $36.00Job Description:Qualifications: Planned, organize, and prioritize complaint investigation activities based on complaint closure and reportability timelines. Perform analysis in No Product Return Evaluations by utilizing multiple data inputs including techn ...
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Quality Engineer
5 days ago
End Point Irvine, United StatesEndpoint is a digital title and settlement company built from the ground up to make home closing easy for all. For many, buying or selling a home is one of life's biggest transactions. At Endpoint, we help our customers close every deal so they can start their next chapter with c ...
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Quality Engineer
3 days ago
Apartment Association of Orange County Irvine, United StatesABOUT US · Orchid Orthopedic Solutions · is world leading Medical Device Contract Design and Manufacturing company that offers a comprehensive portfolio of services for implants and instruments with significant experiencein the joint · reconstruction, spine, trauma, dental and ...
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Quality Engineer
1 week ago
Pacer Staffing Irvine, United StatesJob Title: Quality Engineer · Location: · Irvine, CA · Duration: 12 months (Possibility of extension) · Key Responsibilities · Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all produc ...
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Quality Engineer
4 hours ago
INTELLECTT INC Irvine, United StatesRole: Quality Engineer · Location: Irvine, CA · Duration: 06+ Months on W2 · Job Description: · •Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective an ...
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Quality Engineer
1 week ago
End Point Irvine, United StatesEndpoint is a digital title and settlement company built from the ground up to make home closing easy for all. For many, buying or selling a home is one of life's biggest transactions. At Endpoint, we help our customers close every deal so they can start their next chapter with c ...
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Quality Engineer
1 week ago
Jabil Irvine, United StatesAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast networ ...
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Quality Engineer
2 days ago
Baxter Healthcare Corporation Irvine, United StatesThis is where you save and sustain lives · At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outc ...
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Quality Engineer
1 week ago
Jabil Malaysia Irvine, United StatesAt Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast networ ...
Quality Engineer - Irvine, United States - Aequor Technologies
Description
The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices.Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
This role may also include working with the New Product Introduction (NPI) team to integrate new products developed by R&D into the manufacturing environment.
Job Duties:
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
Minimum Requirements:
Bachelor's degree in Engineering
Preferred Requirements:
2 years of relevant experience in a regulated industry (FDA environment preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
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