Jobs
>
Irvine

    Sr Product Quality Clinician - Irvine, United States - Ledgent Technology

    Ledgent Technology
    Ledgent Technology Irvine, United States

    3 weeks ago

    Default job background
    Description

    Product Quality Clinician

    Duration: 12 months, Temp to Hire (based on performance)

    Location: Remote

    Pay: $40 - $45 an hour

    The main function of a Product Quality Clinician is to provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.

    Key Responsibilities:


    • Analyze complex event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. May review complaint conclusions/closure statements and/or customer letters.


    • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution


    • Analyze complex clinical evaluation reports (CER) regulatory submissions, regulatory agency requests, and/or management report including ad hoc report


    • Provide clinical input to Product Risk Assessments (PRA).


    • Provide training to complaint staff on products and procedures and internal policies and procedures


    • Support Product Safety to maintain Decision Rationale Matrix (DRM) and utilize DRM for reportability


    • Provide knowledge transfer and product training for team members


    • Other incidental duties: Maintain relevant education/training

    Skills:


    • Knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR EU MDR and other applicable regulatory requirements. Ability to classify complaints per FDA standards.


    • Knowledge of cardiac anatomy and physiology


    • Ability to interpret medical device complaints from originator to internal engineering teams for further investigation


    • Excellent facilitation, presentation, and public speaking skills


    • Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills with ability to drive achievement of objectives


    • Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel. Reliance ETQ experience preferred


    • Proven successful project management skills


    • Strict attention to detail


    • Ability to manage competing priorities in a fast paced environment


    • Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects


    • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations


    • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

    Education and Experience:


    • Bachelor's Degree or Equivalent in in related field


    • Experience in the Medical Device Industry, Quality System, and/or hospital/clinical environment (e.g., cardiac care, ICU, OR, or cardiovascular/endovascular interventions) Required

    · Experience as a RN or PA in an ICU, OR/ER, or cardiac environment required


    • Previous experience working in a large manufacturing company Preferred


    • 5-7 years of experience required - open to Sr candidates

    All qualified applicants will receive consideration for employment without regard torace, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status.We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

  • Southern California Alcohol and Drug Programs, Inc.

    Quality Assurance Clinician Registered

    3 weeks ago

    Southern California Alcohol and Drug Programs, Inc. Downey, United States

    About Us: · **Southern California Alcohol and Drug Program** · Southern California Alcohol and Drug Programs, Inc. (SCADP) was established in 1972 in a grassroots effort by community members seeking alternatives to prison for individuals with substance use disorder (SUD). SCADP i ...

  • CYNET SYSTEMS

    Senior Product Quality Clinician

    3 weeks ago

    CYNET SYSTEMS Irvine, United States

    Job Description: · Pay Range $40.10hr - $45.10hr · Responsibilities: Analyze complex event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. · May review complaint conclusions/closure statements and/or customer lett ...

  • Optum

    Bilingual Nurse Practitioner

    2 weeks ago

    Optum Irvine, United States

    Come join our team at Optum where we believe in providing quality of life to our clinicians. We offer excellent work life balance with no call and no weekends. · We are looking for a **Nurse Practitioner for our team in southern Orange County. **This is an excellent position to f ...

  • Pacific Mind Health

    Psychotherapist for Mental Health Wellness Practice

    2 weeks ago

    Pacific Mind Health Irvine, United States

    **Pacific Mind Spa** is a mental health wellness practice with a mission to build a world where everyone has access to exceptional mental healthcare. With several locations across the state, we strive to make quality care affordable while providing a nurturing environment for cli ...

  • Edwards Lifesciences

    Field Clinical Specialist, Orange County/la/inland

    3 weeks ago

    Edwards Lifesciences Irvine, United States

    Job Description · Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offeri ...

  • UC Irvine Campus

    Operations Coordinator

    2 weeks ago

    UC Irvine Campus Irvine, United States

    Updated: Apr 19, 2024 · Location: Irvine-Campus · **Job Type**: · Department: UCI Ctr for Clinical Research · **Job Opening ID**:67931 · **Reports To**: Project Manager · **Working Title**: Operations Coordinator - Hybrid · **Department**: UCI Ctr for Clinical Research · **Bargai ...

  • B. Braun Medical Inc.

    Supervisor I, Manufacturing

    3 weeks ago

    B. Braun Medical Inc. Irvine, United States

    Overview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...

  • B. Braun Medical Inc.

    Inspector

    2 weeks ago

    B. Braun Medical Inc. Irvine, United States

    Overview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...

  • Edwards Lifesciences

    Manager, Clinical Data Management, Critical Care

    1 week ago

    Edwards Lifesciences Irvine, United States

    For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be ...

  • Edwards Lifesciences

    Associate Specialist Patient Support Center

    3 weeks ago

    Edwards Lifesciences Irvine, United States

    Based in Irvine, CA, Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, we collaborate with the world's leading clinicians and resea ...

  • B. Braun Medical Inc.

    Production Lead

    3 weeks ago

    B. Braun Medical Inc. Irvine, United States

    Overview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...

  • Edwards Lifesciences

    Group Brand Manager, Critical Care

    2 weeks ago

    Edwards Lifesciences Irvine, United States

    Job Description · For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every pat ...

  • B. Braun Medical Inc.

    Production Operator

    3 weeks ago

    B. Braun Medical Inc. Irvine, United States

    Overview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...

  • B. Braun Medical Inc.

    Calibration Technician Iii

    2 weeks ago

    B. Braun Medical Inc. Irvine, United States

    Overview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...

  • Coyne & Associates Education Corp

    Behavior Technician

    2 weeks ago

    Coyne & Associates Education Corp Irvine, United States

    No previous Applied Behavior Analysis (ABA) therapy experience is required for this_**Entry Level **_position We will provide the best hands-on ABA training and mentorship in Southern California - W_here you _will actively learn shadowing with kids and trainers _in the field._ · ...

  • Concentra

    X Ray Technician Limited Scope

    2 days ago

    Concentra Irvine, United States

    Overview: · **Schedule: Full Time / 40 hours a week / M-F 8a-5p** · **Location: Irvine, CA (**2362 Morse Avenue)** · Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing exceptiona ...

  • B. Braun Medical Inc.

    Supervisor Ii, Manufacturing

    3 days ago

    B. Braun Medical Inc. Irvine, United States

    Overview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...

  • B. Braun Medical Inc.

    Inspector/ Packer

    1 day ago

    B. Braun Medical Inc. Irvine, United States

    Overview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...

  • Edwards Lifesciences

    Inside Area Sales Specialist, Critical Care

    1 week ago

    Edwards Lifesciences Irvine, United States

    For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be ...

  • Edwards Lifesciences

    Product Manager, Capital Marketing, Critical Care

    4 days ago

    Edwards Lifesciences Irvine, United States

    For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we're committed to creating a world where every patient who should be ...