We have other current jobs related to this field that you can find below

  • Quality Compliance Specialist

    2 months ago

    Irvine, United States Compunnel Inc. Full time

    Job Description: 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 process.•...

  • Quality Compliance Specialist

    2 months ago

    Irvine, United States Compunnel Inc. Full time

    Job Description: 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 process.•...

  • Quality Compliance Specialist, Complaint Management

    2 months ago

    Irvine, United States Compunnel Inc. Full time

    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 expectations during the course of complaint investigation and resolution processResearch, seek information...

  • Air Quality Engineer/Scientist

    3 months ago

    Irvine, United States Yorke Engineering, LLC Full time

    Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly...

  • Air Quality Engineer/Scientist

    3 months ago

    Irvine, United States Yorke Engineering, LLC Full time

    Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly...

  • Clinical Laboratory Quality Assurance Specialist

    7 days ago

    Irvine, California, United States TCWGlobal Full time

    Clinical Laboratory Quality Assurance SpecialistLocation: OnsiteCompensation: $32/hr (Weekly pay + Benefits)Contract Duration: 4 months (Potential for extension and permanent position)Work Schedule: Full-time, Monday to Friday, starting at 7 AM (8-hour shifts)TCWGlobal is a leading organization comprised of innovative thinkers, skilled professionals, and...

  • Regulatory Compliance Specialist

    2 days ago

    Irvine, California, United States Brett Fisher Group - Search Consultants Full time

    Why Consider This Opportunity? Our client, a prominent manufacturer and distributor in the medical device sector, specializes in anesthesia and respiratory solutions. They are recognized for their commitment to innovation, consistently acquiring, licensing, and launching new products globally. With a presence in over 105 countries and operations across 12...

  • Operational Compliance Specialist

    2 days ago

    Irvine, California, United States Hyundai Capital America Full time

    Job SummaryThe Operational Compliance Specialist will play a critical role in ensuring Hyundai Capital America's processes and controls adhere to published policies and procedures, as well as comply with applicable federal and state laws and regulations.Key ResponsibilitiesServe as the subject matter expert on credit reporting and provide compliance advice...

  • Regulatory Compliance Specialist

    7 days ago

    Irvine, California, United States Jobot Full time

    Join a Leading Medical Device Company as a Regulatory Affairs SpecialistAbout the Role:We are seeking a talented and experienced Regulatory Affairs Specialist to become a vital part of our team within the medical device sector. This role is essential in maintaining our compliance with various domestic and international regulations, guidelines, and...

  • Compliance Controls Specialist

    6 days ago

    Irvine, California, United States Alleviatefinancial Full time

    POSITION SUMMARY:The Compliance Controls Specialist plays a vital role within the Compliance Department, tasked with assessing and improving the efficiency of the organization's internal controls.This position requires conducting thorough audits, evaluating potential risks, and offering strategic recommendations to ensure the integrity of the company's...

  • Regulatory Compliance Specialist

    7 days ago

    Irvine, California, United States Insight Global Full time

    Essential Qualifications:Bachelor's Degree in a relevant fieldMinimum of 2 years' experience in regulatory compliance or complaint managementProven track record in managing the complete process of complaint resolution (initiation, investigation, and closure)Experience in preparing and submitting documentation to the FDAFamiliarity with Good Manufacturing...

  • Cloud Security and Compliance Specialist

    7 days ago

    Irvine, California, United States InterEx Group Full time

    Position: Cloud Security and Compliance SpecialistLocation: Irvine, CA (5 days onsite) - RELOCATION SERVICES AVAILABLESponsorship is available if neededJoin InterEx Group, a leading player in the networking hardware industry, as we expand our footprint in the United States. With a global customer base spanning over 170 countries, we are recognized as the...

  • Cloud Security and Compliance Specialist

    7 days ago

    Irvine, California, United States InterEx Group Full time

    Position: Cloud Security and Compliance SpecialistLocation: Remote - RELOCATION SERVICES AVAILABLESponsorship is available if neededJoin InterEx Group, a leading player in the networking hardware industry, as we expand our operations in the United States. With a global customer base spanning over 170 countries, we are recognized as the foremost manufacturer...

  • Quality Assurance Validation Specialist

    7 days ago

    Irvine, California, United States Cynet Systems Full time

    Job DescriptionWe are seeking a Quality Assurance Validation Specialist for our esteemed client.Position: Quality Assurance Validation SpecialistLocation: Not SpecifiedEmployment Type: ContractCompensation: $44.70/hr - $49.70/hrKey Responsibilities:Analyze time, motion, methods, and efficiency in maintenance, production, and other operations to establish...

  • Compliance Controls Specialist

    7 days ago

    Irvine, California, United States Alleviatefinancial Full time

    POSITION SUMMARY:The Compliance Controls Specialist plays a crucial role within the Compliance Department, focusing on the assessment and improvement of the organization's internal control systems.This position entails performing audits, evaluating potential risks, and offering insights to guarantee the integrity of the company's financial reporting,...

  • Lead Tax Compliance Specialist

    3 days ago

    Irvine, California, United States Advantage Solutions Full time

    Lead Tax Compliance SpecialistJob OverviewAs a prominent player in North America's sales and marketing sector, Advantage Solutions specializes in outsourced sales, merchandising, category management, and marketing services tailored for manufacturers, suppliers, and producers of food products and consumer packaged goods. Our diverse service portfolio spans...

  • Labor Compliance Specialist

    2 weeks ago

    Irvine, United States Bernards Full time

    Job Summary:Bernards is seeking new, dynamic Employee-Owners who are committed to the overall Mission, Vision, and Core Values of Bernards to help build A Better Experience. Our ideal Labor Compliance Specialist candidate will work closely with the Labor Compliance Manager and is responsible for accurate monitoring, processing, and recording, of the...

  • Labor Compliance Specialist

    2 weeks ago

    Irvine, United States Bernards Full time

    Job Summary:Bernards is seeking new, dynamic Employee-Owners who are committed to the overall Mission, Vision, and Core Values of Bernards to help build A Better Experience. Our ideal Labor Compliance Specialist candidate will work closely with the Labor Compliance Manager and is responsible for accurate monitoring, processing, and recording, of the...

  • Quality Assurance and Configuration Specialist

    2 days ago

    Irvine, California, United States Turion Space Full time

    Job OverviewAs a Quality Assurance and Configuration Specialist at Turion Space, you will play a crucial role in overseeing and managing the quality and configuration of our satellite fleet and associated subsystems. Your main responsibilities will include leading our internal configuration management processes, which encompass part numbers and release...

  • Senior Quality Assurance Specialist

    7 days ago

    Irvine, California, United States Staco Systems Full time

    Job OverviewSenior Quality Assurance SpecialistPosition SummaryThis role is responsible for the thorough inspection, auditing, and reporting of materials, processes, products, and calibrated equipment utilized in the production of buttons, switches, and subsystems. The objective is to ensure compliance with established requirements and quality standards...

Associate Quality Compliance Specialist

2 months ago

Irvine, United States Hydrogen Group Full time

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 Edwards 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

Education and Experience:

  • Bachelor's Degree or equivalent in related field
  • 2 years of experience required
  • Class III Medical Device reporting