Quality Compliance Specialist

3 weeks ago


Irvine, United States Planet Pharma Full time

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



  • 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...


  • Irvine, United States Leonid Group Ltd Full time

    This 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 Leonid Group Ltd Full time

    This 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 Leonid Group Ltd Full time

    This 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 Irvine Ranch Water District Full time

    General Description Irvine Ranch Water District is currently accepting applications for a Regulatory Compliance Specialistin our Regulatory Compliance Department. The District Irvine Ranch Water District (IRWD) is a progressive, values-driven agency, with an international reputation for its leading-edge financial management practices, water recycling...


  • Irvine, United States Trinus Full time

    Job 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...


  • Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

    Quality 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...


  • Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

    Quality 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...


  • Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

    Quality 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...


  • Irvine, United States Leonid Group Ltd Full time

    This 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 Leonid Group Ltd Full time

    This 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 Leonid Group Ltd Full time

    This 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 Safran Group Full time

    1. 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...

  • Quality Engineering

    3 weeks ago


    Irvine, United States INTELLECTT INC Full time

    Role : Quality Engineering / Compliance Specialist Location : Irvine, CA - 92614 Duration : 9 Months Skills Looking For Working on complaint evaluation for a medical device company Responsibilities include intake, investigation, and summary writing for complaints Basic computer proficiency required. Experience with quality management systems is preferred but...

  • SIU Investigator

    2 weeks ago


    Irvine, United States Frasco Inc Full time

    Job 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...


  • Irvine, United States Laird Connectivity Full time

    The 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...


  • Irvine, United States Cypress HCM Full time

    Documentation SpecialistThe Documentation Specialist who will be responsible for supporting the manufacturing of products by creating, processing and reviewing production batch records. The Doc Specialist will follow established GDP & GMP processes and procedures.Summary:Review documents for format, accuracy and compliance with existing procedures; provide...


  • Irvine, United States Cypress HCM Full time

    Documentation SpecialistThe Documentation Specialist who will be responsible for supporting the manufacturing of products by creating, processing and reviewing production batch records. The Doc Specialist will follow established GDP & GMP processes and procedures.Summary:Review documents for format, accuracy and compliance with existing procedures; provide...

  • Quality Manager

    13 hours ago


    Irvine, California, United States Balt Full time

    About Balt Our purpose is to improve the lives of 150,000 patients in Our story Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11...

  • Quality Manager

    11 hours ago


    Irvine, California, United States Balt Full time

    About Balt Our purpose is to improve the lives of 150,000 patients in Our story Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11...