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Immucor, Inc. Associate Director, Quality Operations in Warren, New Jersey


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.

The Associate Director, Quality Operations is responsible for leading continual improvement activities to enhance the quality system processes. Our ideal candidate will have experience providing input, oversight and coordination of quality data trending activities to ensure high quality, reliability and consistent performance. The incumbent will establish and implement procedures and policies needed to meet the demands of document control within a regulated medical device company. Additional responsibilities include managing the inspection readiness program, ensuring that laboratory services are of the best quality, cost contained and carried out in an expeditious manner. As an employee of Immucor, you will recognize results or problems that require escalation to the Sr. Director Quality Operations, assuring competency of all personnel, formulating the budget for the department, maintaining performance improvement activities within the department and participate in continuous improvement activities. Maintain efficient and effective departmental operations in compliance with all state, federal, and local regulatory laws, standards and protocols. 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 .

Associate Director - Quality System


  • Ensures that all Quality System procedures and documents are maintained and controlled according to regulatory requirements and internal Standard Operating Procedures (SOP)s

  • Support the design and development of new products and participates in process design and development of core team activities

  • Manages the Quality Review Board and Management Review data collection, analysis data and present to the executive leadership team

  • Coordinates the review/approval of documentation including, but not limited to investigations, CAPAs, protocols, reports, procedures, change orders, etc. for conformance to written specifications, SOPs, and applicable regulations (inclusive by not limited to: FDA, Health Canada, ISO 13485, MDSAP, OSHA, etc.).

  • Work with manufacturing operations in planning, organizing and directing laboratory services to ensure compliance with product release schedules and testing requests

  • Prepares reports by collecting, analyzing and summarizing quality data

  • Identifies trends and causes of non-conformance and introduce and follow-up with appropriate corrective actions to eliminate causes of non-conformance

  • Prepare department budgets for personnel, operating expenses and capital equipment

  • Consult with other departments as appropriate to collaborate in product testing discrepancy resolutions and improvement activities

  • Responsible for the implementation, monitoring and evaluation of performance improvement and continuous improvement activities

  • Direct and participate in the human resource management function for the department by coordinating the selection, promotion, orientation and performance appraisal processes

  • Coordinate the department's training

  • Actively participate in site committees and programs (i.e. internal audits, validation, change control, CAPA Review Board, OOS board, manufacturing operations review, etc.) as appropriate

  • Act on behalf of the Sr. Quality Operations Director as a Management Representative when required

Associate Director - Quality System


  • Bachelor of Science degree in Life Sciences (Molecular, Biology, Chemistry or Engineering) from a four-year college or university; or equivalent combination of education and experience, required

  • 5 -7 years' direct experience supervising employees in multiple departments

  • Ability to work independently, exercise creativity, extreme attention to detail

  • Experience managing multiple responsibilities and prioritize scheduling of work

  • Strong organizational and interpersonal skills

  • Excellent communication skills, both orally and in writing

  • Ability to determine appropriate course of action in complex situations and responding to high level inquiries and complaints

  • Preferred certifications ASQ, CQE, CQA or other relevant quality assurance certification

Associate Director - Quality System

Job ID 2019-2007

Category Quality

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