THV Quality Assurance Specialist
1 month ago
We are seeking a highly skilled THV Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and compliance, with experience in medical device testing and investigation.
The successful candidate will be responsible for investigating product quality issues, performing device testing, and managing complaint investigations. They will also be required to analyze results to determine root causes and probable causes, and participate in escalation tasks such as Project Risk Assessments and Corrective/Preventive Actions.
The THV Quality Assurance Specialist will work closely with manufacturing teams to resolve production/device related issues, and will be responsible for reporting key complaint metrics by device category.
The ideal candidate will have a Bachelor's degree in engineering, with 0-2 years of related work experience. They will also have experience with medical device complaint investigations, including CAPAs, NCRs, and Root-Cause Analysis.
Benefits include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan.
Key Responsibilities:
- Investigate complex product quality and compliance issues from the field
- Perform hands-on device investigation using various test equipment
- Assess events against risk documentation for clinical/compliance risks
- Participate in escalation tasks such as Project Risk Assessments and Corrective/Preventive Actions
- Report key complaint metrics by device category
Requirements:
- Bachelor's degree in engineering
- 0-2 years of related work experience
- Experience with medical device complaint investigations
- Proficiency with the Microsoft Office suite
-
Senior Biostatistician, THV
1 month ago
Irvine, California, United States Edwards Lifesciences Full timeTransform Patient Care with Statistical ExpertiseAortic stenosis affects millions worldwide, yet often remains under-diagnosed and undertreated. Edwards' pioneering work in transcatheter aortic heart valve replacement (TAVR) has revolutionized patient care. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States Innova Solutions Full timeQuality Assurance SpecialistInnova Solutions is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services. This includes conducting inspections, testing, and audits to ensure compliance with regulatory requirements and company standards.Key...
-
Quality Assurance Specialist
1 month ago
Irvine, California, United States 22nd Century Technologies Full timeJob Title:Quality Assurance SpecialistJob Summary:22nd Century Technologies is seeking a Quality Assurance Specialist to develop and maintain quality standards and evaluation methods for products and processes. The ideal candidate will have a strong background in engineering and quality assurance, with experience in statistical process control and quality...
-
Quality Assurance Specialist
3 weeks ago
Irvine, California, United States B. Braun Medical Inc Full timeAbout B. Braun Medical Inc.B. Braun Medical Inc. is a leading manufacturer of medical products and services. We are seeking a Quality Assurance Specialist to join our team in Irvine, CA.Job Summary:The Quality Assurance Specialist will be responsible for ensuring compliance with quality requirements, verifying documentation and test reports, and filing...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States Radiant Systems Inc Full timeJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Radiant Systems Inc. As a Quality Assurance Specialist, you will be responsible for supporting in-process testing of raw materials, intermediates, and Client Controls.Key Responsibilities:Operate, maintain, calibrate, and troubleshoot clinical diagnostic laboratory...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States B. Braun Medical Inc. Full timeAbout the RoleB. Braun Medical Inc. is seeking a Quality Assurance Specialist to provide support to production for quality activities and maintain oversight of manufacturing activities for quality compliance.The successful candidate will work closely with cross-functional teams to identify and mitigate quality risks, audit production processes, and conduct...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States B. Braun Medical Inc Full timeAbout B. Braun Medical Inc.B. Braun Medical Inc., a leading manufacturer of medical products, is seeking a Quality Assurance Specialist to join its team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of finished Excel products. Your duties will include performing visual in-process inspections, verifying documentation,...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States Integra LifeSciences Full timeQuality Assurance SpecialistAt Integra LifeSciences, we are committed to delivering high-quality products that meet the needs of our customers. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and safety.Key Responsibilities:Lead critical Supplier Quality related projects and...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States B. Braun Medical Inc Full timeAbout B. Braun Medical Inc.B. Braun Medical Inc. is a leading manufacturer of medical products and services. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our products, specifically Excel products. Your responsibilities will include visual in-process inspection, documentation, and filing of quality batch records....
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States B. Braun Medical Inc Full timeJob Summary:As a Quality Assurance Specialist at B. Braun Medical Inc., you will play a crucial role in ensuring the quality of our products. Your primary responsibility will be to verify the documentation and test reports of all tests conducted, ensuring compliance with quality requirements. You will also be responsible for filing, compiling, and...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States Mastech Digital Full timeJob Title: Quality Assurance SpecialistLocation: Irvine, CA 92614 (Onsite)Contract PositionRequirements:High School Diploma (required);3+ years related experience to include experience using sophisticated dimensional measurement instruments such as micrometers, calipers, plug thread, optical comparator, borescope, and other gauges.Experience preparing,...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States Mastech Digital Full timeJob Title: Quality Assurance SpecialistLocation: Contract PositionRequirements:High School Diploma (required);3+ years related experience to include experience using sophisticated dimensional measurement instruments such as micrometers, calipers, plug thread, optical comparator, borescope, and other gauges.Experience preparing, executing, and reviewing First...
-
Quality Assurance Specialist
1 month ago
Irvine, California, United States Search Masters, Inc Full timeJob SummarySearch Masters, Inc is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality management team, you will be responsible for assisting the quality manager in creating, maintaining, and distributing documentation in accordance with our quality management system: ISO9001.Key Responsibilities:Plan,...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States TCWGlobal Full timeJob OverviewOur client, a global leader in life science research and healthcare, is seeking a Quality Assurance Specialist to support the compilation and maintenance of IVDR technical files. The successful candidate will review and process labeling and FOC change requests, compile and create quality-related technical file documentations, and perform various...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States B. Braun Medical Inc Full timeJob Summary:As a Quality Assurance Specialist at B. Braun Medical Inc., you will play a crucial role in ensuring the quality of our Excel products. Under general supervision, you will perform visual in-process inspections to verify compliance with quality requirements. Your responsibilities will include verifying documentation, filing quality batch records,...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States Cypress HCM Full timeJob DescriptionCypress HCM is seeking a skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for operating, maintaining, calibrating, and troubleshooting clinical diagnostic laboratory instruments.Key Responsibilities:Operate and maintain clinical diagnostic laboratory instruments to ensure accurate and reliable test...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States Cypress HCM Full timeCypress HCM is seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in science and experience working in a clinical or manufacturing environment.Key Responsibilities:Education: Associate's degree or higher in a science field or equivalent clinical lab experienceWork Experience: 2+ years in...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States ConsultNet Full timeJob Summary:We are seeking a skilled Quality Assurance Specialist to join our team at ConsultNet. The successful candidate will be responsible for performing inspections in receiving, shop, and assembly operations, providing technical assistance on inspection and measurement systems, and operating CMM for critical inspections, including GD&T inspections.Key...
-
Quality Assurance Specialist
4 weeks ago
Irvine, California, United States B. Braun Medical Inc Full timeJob Summary:As a Quality Assurance Specialist at B. Braun Medical Inc., you will play a critical role in ensuring the quality and integrity of our Excel products. Under general supervision, you will perform visual in-process inspections to verify compliance with quality requirements. Your attention to detail and commitment to excellence will be essential in...
-
Electrical Quality Assurance Specialist
4 weeks ago
Irvine, California, United States NV5 Full timeJob SummaryWe are seeking an experienced Electrical Quality Assurance Specialist to join our team at NV5. As an Electrical Quality Assurance Specialist, you will serve as an Owners Representative for Clean Mobility Infrastructure projects, providing field quality assurance at multiple sites during various phases of construction to identify common...