Quality Compliance Specialist
2 weeks ago
12 month contract, pay $34/hr
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
Additional Skills:
- Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Excellent written and verbal communication skills and interpersonal relationship skills
- Demonstrated problem-solving , critical thinking, and investigative skills
- Full knowledge and understanding of policies, procedures, and guidelines relevant to quality compliance
- Good knowledge of medical terms and human anatomy
- Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
- Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
- Ability to manage confidential information with discretion
- Attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Work is performed independently on complex work and reviewed for accuracy and soundness
Education and Experience:
- Bachelor's Degree or equivalent in related field
- 1+ years of experience required
-
Quality Compliance
2 weeks ago
Irvine, United States Intellectt Inc Full timeRole: Assoc Spec, Quality ComplianceLocation: Irvine, CA - 92614Duration: 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 appropriateKey Responsibilities:Manage customer relationships and...
-
Quality Compliance
2 weeks ago
Irvine, United States Intellectt Inc Full timeRole: Assoc Spec, Quality ComplianceLocation: Irvine, CA - 92614Duration: 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 appropriateKey Responsibilities:Manage customer relationships and...
-
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...
-
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...
-
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...
-
Quality Assurance Specialist
3 days ago
Irvine, United States Tucker Parker Smith Group (TPS Group) Full timeQuality Assurance SpecialistLocation: Irvine, CAHours: 7:00 AM - 3:30 PM, OnsitePay Rate: $27/hr.9 month contract (Great potential to extend or convert)On behalf of our client a pharmaceutical company focused on the development of medical devices for the life science industry. We are seeking an Entry-Level Documentation Specialist to join their team in...
-
Quality Assurance Specialist
3 days ago
Irvine, United States Tucker Parker Smith Group (TPS Group) Full timeQuality Assurance SpecialistLocation: Irvine, CAHours: 7:00 AM - 3:30 PM, OnsitePay Rate: $27/hr.9 month contract (Great potential to extend or convert)On behalf of our client a pharmaceutical company focused on the development of medical devices for the life science industry. We are seeking an Entry-Level Documentation Specialist to join their team in...
-
Quality Assurance Specialist
2 days ago
Irvine, United States Tucker Parker Smith Group (TPS Group) Full timeQuality Assurance SpecialistLocation: Irvine, CAHours: 7:00 AM - 3:30 PM, OnsitePay Rate: $27/hr.9 month contract (Great potential to extend or convert)On behalf of our client a pharmaceutical company focused on the development of medical devices for the life science industry. We are seeking an Entry-Level Documentation Specialist to join their team in...
-
Quality Assurance Specialist
4 days ago
Irvine, United States Tucker Parker Smith Group (TPS Group) Full timeJob DescriptionJob DescriptionQuality Assurance Specialist (Pharmaceutical)Location: Irvine, CAHours: 7:00 AM - 3:30 PM, OnsitePay Rate: $27/hr.9 month contract (Great potential to extend or convert)On behalf of our client a pharmaceutical company focused on the development of medical devices for the life science industry. We are seeking an Entry-Level...
-
Director of Compliance
1 week ago
Irvine, United States Safran Group Full time1. Job Summary The Director of Compliance manages and leads all activities related to export controls, import/customs controls, trade compliance and risk management. The role leads and manages a team of import and export specialists and oversees, develops, implements and executes policies, procedures and practices related to national, international and...
-
Director of Compliance
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...
-
Director of Compliance
24 hours 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...
-
Director of Compliance
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...
-
Irvine, United States Compunnel Full timeSummary: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 processResearch, seek information...
-
Irvine, United States Compunnel Full timeSummary: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 processResearch, seek information...
-
SR Quality systems specialist
3 days ago
Irvine, United States Becton, Dickinson & Company Full timeWe are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat. It takes the imagination and passion of all of usfrom design and engineer Quality, Systems, Specialist, QA Manager, Manufacturing, Technology, Support, Audit
-
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...
-
Senior Quality Assurance Specialist
2 weeks ago
Irvine, United States Laird Connectivity Full timeThe Senior Quality Assurance Specialist is responsible for, but not limited to, development, maintenance, coordination and implementation of the Quality Business System in assigned facility. The incumbent will apply knowledge of quality systems and interact with/and provide guidance to functional managers, engineers, and operators in order to meet quality...
-
Senior Quality Assurance Specialist
4 days ago
Irvine, United States Laird Connectivity Full timeThe Senior Quality Assurance Specialist is responsible for, but not limited to, development, maintenance, coordination and implementation of the Quality Business System in assigned facility. The incumbent will apply knowledge of quality systems and interact with/and provide guidance to functional managers, engineers, and operators in order to meet quality...