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Quality Engineering Manager
2 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
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
6 days 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
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
2 weeks ago
Aequor Technologies Irvine, United StatesThe 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 ...
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Quality Engineer
1 hour 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
5 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
6 days 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
6 days 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
5 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
4 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
2 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
6 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
6 days 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
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 Engineering
1 week ago
INTELLECTT INC Irvine, United StatesRole : Quality Engineering / Compliance Specialist · Location : Irvine, CA · Duration : 9 Months · Skills Looking For · Working on complaint evaluation for a medical device company · Responsibilities include intake, investigation, and summary writing for complaints · Basic co ...
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Quality Engineer
6 days 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
6 days 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 ...
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Quality Engineer
1 hour 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 ...
Quality Engineer - Irvine, United States - Motion Recruitment
Description
Title: 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 monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless innovation, our partner stands at the forefront of revolutionizing healthcare. Key offerings include transcatheter heart valves, innovative transcatheter mitral solutions, advanced critical care monitoring systems, and state-of-the-art surgical valve technologies.
Overview:
The main function of the Quality Engineer is to lead all software engineering activities relating to the validations of several production equipment with custom software. The main purpose of this role is to apply knowledge of software quality engineering to assess risk, execute validation activities and develop/approve software documents.
Job Responsibilities:
• Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.
• Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.
• Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.
• Perform dry-runs and execution of Software Validation Protocols.
• Train, coach, and guide other employees on software documentation.
• Other Incidental duties as required.
Required Skills:
• Proven expertise in usage of MS Office Suite;
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
• Working knowledge and understanding of statistical techniques.
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software.
• Substantial knowledge of business acumen products and software technologies
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software).
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Level of Independence:
• Works independently without close supervision.
• Compares and evaluates possible courses of action after considering various possibilities.
• Applies knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met.
• Considers the cause and effect of activities.
• Determines or effectively recommends course of action after considering potential risks of alternatives.
• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive.
Education/Experience:
• Bachelor's degree in engineering required.
• 2-4 years experience required.
• Previous experience with software verification and validation activities in a medical device industry.