Quality Compliance
2 weeks ago
Role: Assoc Spec, Quality Compliance
Location: Irvine, CA - 92614
Duration: 12 Months
Job Description:
Summary:
- The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
Key Responsibilities:
- Manage customer relationships and expectations during the course of complaint investigation and resolution process
- Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
- Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
- Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
- Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
- Prepare and submit final customer correspondence
- Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint
-
Quality Compliance
1 week ago
Irvine, United States INTELLECTT INC Full timeRole: Assoc Spec, Quality Compliance Location: Irvine, CA - 92614 Duration: 12 Months Job Description: Summary: The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate Key Responsibilities: Manage customer relationships...
-
Assoc Spec, Quality Compliance
2 weeks ago
Irvine, United States Trinus Full timeJob DescriptionJob DescriptionSummary: The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriateKey Responsibilities: Manage customer relationships and expectations during the course of complaint investigation and resolution...
-
Compliance Analyst
1 week ago
Irvine, United States ConsumerDirect, Inc. Full timeJob DescriptionJob Description***Local candidates ONLY – this position is on-site Monday – Friday.***About ConsumerDirect:ConsumerDirect is the people-first-financial platform and creator of smartcredit.com, scoremaster.com, and the HOGO app. We’re the first and only company to combine credit, privacy, money management, and identity protection all in...
-
Export Compliance Specialist
2 days ago
Irvine, United States Leonid Group Ltd Full timeThis is an exciting opportunity to join a global leader in aerospace and defense renowned for its groundbreaking technologies and solutions.Our client specializes in providing cutting-edge engines, systems, and equipment for both civil and military aircraft. With a steadfast commitment to research and development, they continuously push the boundaries of...
-
Export Compliance Specialist
2 days ago
Irvine, United States Leonid Group Ltd Full timeThis is an exciting opportunity to join a global leader in aerospace and defense renowned for its groundbreaking technologies and solutions.Our client specializes in providing cutting-edge engines, systems, and equipment for both civil and military aircraft. With a steadfast commitment to research and development, they continuously push the boundaries of...
-
Quality Engineer
13 hours ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 Both are short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I/II (Complaint Investigations)Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob...
-
Quality Engineer
8 hours ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 Both are short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I/II (Complaint Investigations)Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob...
-
Quality Engineer
17 hours ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1 Both are short-term (3 months only with no possibility of extension/conversion) contract jobs.Position: Quality Engineer I/II (Complaint Investigations)Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob...
-
Quality Engineer
16 hours ago
Irvine, United States TalentBurst Full timePosition: 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 engineering, 0 - 4 years of experience related work experience required Proficient with the...
-
Quality Engineer
4 weeks ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I/IILocation: Irvine, CA (100% onsite)Duration: 3 Months ContractJob 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 globally reported complaints for returned/non-returned devices. The role...
-
Quality Engineer
1 month ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I/IILocation: Irvine, CA (100% onsite)Duration: 3 Months ContractJob 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 globally reported complaints for returned/non-returned devices. The role...
-
Quality Engineer
2 weeks ago
Irvine, United States TalentBurst Full timePosition: 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 investigations on globally reported complaints for returned/non-returned devices. The...
-
Quality Engineer
2 weeks ago
Irvine, United States Motion Recruitment Full timeTitle: Engineer-1 (Quality) Location: Irvine, CADuration: 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...
-
Quality Engineer
2 weeks ago
Irvine, United States Motion Recruitment Full timeTitle: Engineer-1 (Quality) Location: Irvine, CADuration: 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...
-
Quality Engineer
4 weeks ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description:Education and Experience:Bachelor's degree in engineering, 0 - 4 years of experience related work experience requiredProficient with the...
-
Quality Engineer
4 weeks ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description:Education and Experience:Bachelor's degree in engineering, 0 - 4 years of experience related work experience requiredProficient with the...
-
Quality Engineer
1 month ago
Irvine, United States TalentBurst, an Inc 5000 company Full timePosition: Quality Engineer I (Complaint Investigations), Req#: 6086-1Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1Location: Irvine, CA (100% onsite)Duration: 3 Months ContractJob Description:Education and Experience:Bachelor's degree in engineering, 0 - 4 years of experience related work experience requiredProficient with the...
-
Quality Engineering Manager
2 days ago
Irvine, United States Eaton Full timeEaton’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 expected annual salary range for this role is $105225.03 - $154330.04 a year....
-
SIU Investigator
6 days ago
Irvine, United States Frasco Inc Full timeJob DescriptionJob DescriptionDescription:DescriptionABOUT US: Frasco Investigative Services, a division of Frasco, Inc., provides unparalleled quality investigations throughout the entire United States. Frasco is a full-service investigation corporation serving the insurance, legal, employment, and entertainment communities. Our client base includes many of...
-
Sr. Quality Engineer
5 days ago
Irvine, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management. Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and...