Quality Assurance Compliance Specialist
2 weeks ago
Job Title: Quality Compliance Specialist (Complaint Handling)
Pay Rate: $35 to $39.05/HR
Duration: 12 months
Location: Irvine, CA (Onsite)
Shift: 8 am PST to 5 pm PST (can come in earlier or later if needed, the team is flexible)
Our Client is a Global medical device Manufacturer.
We are looking for a Quality Compliance Specialist (Complaint Handling) to assess the complaint information provided; evaluate each event for determine if it qualifies as a complaint; escalate as appropriate
- Manage customer relationships and expectations during the course of the 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 causes, resolve open action items, and gather additional technical information to resolve the complaint.
Must haves:
- High volume (30 to 50) complaint-handling experience with medical devices (class II or class III). This team mostly manages reintervention complaints.
- Strong computer literacy (office suite required, Adobe is a plus)
- Experience with complaint handling software, ELS uses Reliance ETQ.
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 our 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 a related field
- 1+ years of experience required
-
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...
-
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...
-
Senior Quality Assurance Specialist
4 weeks ago
Irvine, United States Kelly Science, Engineering, Technology & Telecom Full timeKelly Science & Clinical is excited to connect you and this Senior Quality Assurance Data Reviewer Position at a Global Leader Pharmaceutical Company in the Irvine, CA Area.65k-75K/SalaryFull timeDirect HireRESPONSIBILITIES:Review all QC HPLC, GC, CE , AAS. TOC, UV, KF, FTIR and NIR assay and impurity results for Raw Materials, Finished Goods, Stability...
-
Senior Quality Assurance Specialist
4 weeks ago
Irvine, United States Kelly Science, Engineering, Technology & Telecom Full timeKelly Science & Clinical is excited to connect you and this Senior Quality Assurance Data Reviewer Position at a Global Leader Pharmaceutical Company in the Irvine, CA Area.65k-75K/SalaryFull timeDirect HireRESPONSIBILITIES:Review all QC HPLC, GC, CE , AAS. TOC, UV, KF, FTIR and NIR assay and impurity results for Raw Materials, Finished Goods, Stability...
-
Senior Quality Assurance Specialist
4 weeks ago
Irvine, United States Kelly Science, Engineering, Technology & Telecom Full timeKelly Science & Clinical is excited to connect you and this Senior Quality Assurance Data Reviewer Position at a Global Leader Pharmaceutical Company in the Irvine, CA Area.65k-75K/SalaryFull timeDirect HireRESPONSIBILITIES:Review all QC HPLC, GC, CE , AAS. TOC, UV, KF, FTIR and NIR assay and impurity results for Raw Materials, Finished Goods, Stability...
-
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...
-
Quality Assurance Technician
3 weeks ago
Irvine, United States Brothers Desserts Full timeJob DescriptionJob DescriptionJOB SUMMARY: The Quality Assurance Technician will play a critical role in ensuring the quality and safety of our products. Your primary responsibility will be to monitor and test our ice cream products at various stages of production to ensure compliance with quality standards, food safety regulations, and customer...
-
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 Inspector
4 weeks ago
Irvine, United States Glidewell Dental Full timeEssential Functions:Performs incoming receiving goods inspection.Conducts raw material testing to ensure product quality.Performs return material/product inspection (RMA).Authorizes the release of incoming raw materials and finished goods.Performs in-process, semi-final, and final inspections according to drawing and specificationsCompletes inspection...
-
Quality Assurance Inspector
1 month ago
Irvine, United States Glidewell Dental Full timeEssential Functions:Performs incoming receiving goods inspection.Conducts raw material testing to ensure product quality.Performs return material/product inspection (RMA).Authorizes the release of incoming raw materials and finished goods.Performs in-process, semi-final, and final inspections according to drawing and specificationsCompletes inspection...
-
Quality Assurance Inspector
4 weeks ago
Irvine, United States Glidewell Dental Full timeEssential Functions:Performs incoming receiving goods inspection.Conducts raw material testing to ensure product quality.Performs return material/product inspection (RMA).Authorizes the release of incoming raw materials and finished goods.Performs in-process, semi-final, and final inspections according to drawing and specificationsCompletes inspection...
-
Quality Assurance Associate Director
2 weeks ago
Irvine, United States Pharmaron Full timeJob DescriptionJob DescriptionAre you ready to embark on an exciting journey with a company that's passionate about making a difference? Look no further - As Pharmaron continue to grow, we are seeking to add a highly skilled and experienced Quality Assurance Associate Director to join our team to play a key role in the implementation of our quality...
-
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...