Immucor, Inc. Quality Lead in Warren, New Jersey

Overview

We are looking for a Quality Lead to join our Quality Assurance team. The Quality Lead functions as part of the team under the direction of the Site Quality Leader. The team is responsible for coordinating and executing, in a timely fashion, all activities necessary to maintain compliance with GMP and ISO 13485 and the integrity of the Quality Management System. The Quality Lead is responsible for identifying and leading continuous improvement projects with cross-functional team members.

Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics products 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 patients in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or a specific 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!

Quality Lead - Quality Assurance

Responsibilities

The Quality Lead is responsible for ensuring compliance with applicable domestic and international standards and regulations through process review, approval, audits, and systematic maintenance of quality systems. Responsibilities also include assisting the Quality management and actively participating in department activities and projects.

Additional responsibilities of the Quality Lead include:

  • Assists in developing and revising quality systems procedures to maintain compliance with internal and external standards and regulations.

  • Understands Change Control requirements. Reviews and assesses the appropriateness of document changes in accordance with internal procedures including those of a difficult and complex nature.

  • Assists the Quality management and actively participate in department activities and projects.

  • Prepares appropriate, agendas and meeting minutes without supervision.

  • Monitors the progress of items on meeting agendas and reports progress, as appropriate.

  • Serves as custodian for all controlled documents and records filed in the Document Control Center or archived at the on-site warehouse or off-site contracted storage facility.

  • Responsible for storage, retrieval and archiving of controlled documents and records.

  • Effectively follow policies, procedures and quality management system.

  • Serves as QA interface to other departments and/or partners.

  • Contributor to CAPA and NCMR System. This includes reviewing adequacy of root cause, corrections, corrective actions, preventive actions, and effectiveness.

  • Assist and own applicable portions of the supplier management system.

  • Participate in the internal audit program. Perform and review audits as assigned.

  • Assist in external and regulatory body audits.

  • Perform other duties as assigned.

Quality Lead - Quality Assurance

Qualifications

To qualify for the Quality Lead, you must have previous medical device and/or IVD experience and the ability work independently to manage and prioritize workload and assignments.

Additional requirements of the Quality Lead include:

  • Bachelor's degree from four-year college or university; or equivalent combination or education and experience

  • 3-5 years of experience

  • ASQ Certified Quality Auditor, preferred

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

  • Proficiency in MS Office; experience with an eDMS is preferred

  • Communicate effectively and professionally with all suppliers and contractors

Quality Lead - Quality Assurance

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITIES/FEMALES/DISABLED/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 2018-1853

Category Quality