Immucor, Inc. Field Quality Specialist - Warren in Warren, New Jersey

Overview

Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient/donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for a patient in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or an organ as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together!

We are looking to hire a Field Quality Specialist (Quality Investigator) in our Warren, NJ office. This position is responsible for complaint data entry, as well as investigation, review, follow-up, closure, and trend analysis on complaint data. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .

Field Quality Specialist - Quality Investigator

Responsibilities

As a Field Quality Specialist (Quality Investigator), you will monitor the progress of investigations and interact with various departments to resolve issues, complete investigations and close complaints, CAPA, internal and external audits, and supplier corrective actions. You will also maintain quality system compliance with ISO 13485, QSR & IVDD, including creating new/revising existing quality system documentation and facilitating document and change control orders following the change control procedure.

Additional duties for the Field Quality Specialist (Quality Investigator) include:

  • Processing customer complaints, inquiries and feedback in accordance with Immucor procedure

  • Processing CAPAs and tracking activities to completion as required

  • Processing document and change control orders to completion

  • Performing Internal and Supplier Audits and tracking to completion

  • Preparing Field Action documentation as required

  • Performing assessment for potential MDRs and escalating reportable events to Regulatory Affairs

  • Performing evaluation of products returned for the purposes of a complaint investigation

  • Maintaining filing archives for all job-related quality records to ensure controlled access is maintained at all times

  • Preparing metrics for Management Review and supporting data with a compilation of trends and Quality Metrics Scorecards

Field Quality Specialist - Quality Investigator

Qualifications

We are looking for a reliable and results-focused Field Quality Specialist (Quality Investigator) who can communicate effectively and professionally with customers as well as Immucor personnel. Additionally, strong analytical, problem-solving and multi-tasking skills are essential to this role.

Specific qualifications for the Field Quality Specialist (Quality Investigator) position include:

  • Bachelor's degree in Life Sciences

  • ASQ Certified Supplier Quality Professional and/or Auditor preferred

  • Working knowledge of 21 CFR 820, ISO 13485, EU IVDD

  • Previous medical device, pharmaceutical and/or IVD experience required

  • Previous experience with investigation and use of RCA tools required

  • Proficiency in MS Office

  • Experience with an Master Control and TrackWise preferred

  • Limited overnight travel may be required, approximately 5%

Field Quality Specialist - Quality Investigator

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABILITY/VETS; *DRUG FREE WORKPLACE

RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED.

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Job ID 2019-1947

Category Quality