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Job Information

Immucor, Inc. Manager, Quality Operations in Norcross, Georgia

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 Quality Operations Manager. The Quality Operations Manager is responsible for leading continual improvement activities to enhance the quality system processes including but not limited to in-coming and in-process inspections, device history record review, product release transaction, deviation management, out of specification results and control of non-conforming product or material. 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 .

Manager, Quality Operations - (Assurance – Control - Operations)

Responsibilities

As the Quality Control and Operations Manager, you will be responsible for providing input, oversight and coordination of quality data trending activities to help ensure high quality, reliable, consistent performance. The Quality Operations Manager is responsible for coordinating and conducting internal audits of manufacturing processes to ensure compliance with internal procedures and for the correction of any identified non-conformance. Responsible for the maintenance and execution of the CAPA and Change Control programs. The Quality Operations Manager helps to ensure conformance to Regulatory requirements by developing and executing quality strategies that enable the company to achieve strategic and tactical visions for the delivery of high quality products and services that meet customer requirements and drive customer satisfaction.

Your essential duties and responsibilities include:

  • Lead continual improvement activities to enhance the quality system processes including in-coming and in-process inspections, Device History Record review, product release transaction, deviation management, out of specification results and control of non-conforming product or material.

  • Lead the implementation of data trending programs and assist Manufacturing Operations staff in the interpretation of data and in correcting causes of out of control conditions. Lead updates to Risk Management Documentation as appropriate.

  • Develop and establish quality procedures and systems for inspecting plans, quality trends, statistical plan and control plans using statistical methods relevant to manufacturing processes.

  • Prepare reports by collecting, analyzing, and summarizing quality data. Identify trends and causes of non-conformance, introduce and follow-up appropriate corrective actionsto eliminate the causes of non-conformance. Use data obtained to lead execution of Post Market Surveillance activities across departments.

  • Manages the Quality Review Board and Management review data collection, analysis and presentation in Power Point or Excel formats.

  • Coordinate the execution of the approved internal audit program schedule. Participate as an auditor in the internal audit program.

  • Manage the inspection readiness program.

  • Assist the Management Representative in escorting and providing information to regulatory officials during company audits.

  • Produce and revise Quality Operations procedures and other documentation as required, in accordance with established procedures. Interact with manufacturing and engineering teams to optimize documentation related to quality and inspection checks.

  • Conduct training and certification classes as required

  • Contributes to team effort by accomplishing related results as needed.

  • Participate as Quality Representative on Research and Development project design core teams for projects that have a direct impact on manufacturing and/or Quality Lab testing activities.

Manager, Quality Operations - (Assurance – Control - Operations)

Qualifications

We are looking for a Quality Operations Manager with a blend of strong leadership and technical skills including daily management of activities in line with corporate objectives and priorities, resource management inclusive of associate performance management, and strategy development related to the support role and the function this team provides.

Specific qualifications for the role include:

  • Bachelors’ degree in related industry, Engineering / Life Sciences degree or equivalent.

  • ASQ certifications desired

  • Minimum 5 years experience in a similar position in Quality/Engineering in an FDA regulated Industry.

  • Intermediate MS Office computer skills

  • Excellent written and verbal communications skills

  • Strong consultative and interpersonal skills.

  • Ability to prioritize and multi-task.

  • Strong attention to detail and ability to summarize and communicate at all levels of the organization.

  • Team player (displays enthusiasm, confidence & commitment).

  • Exceptional communication ability (verbal & written).

  • Strong presentation skills.

  • Ability to take initiatives and work independently.

  • Strong problem solving and analytical skills.

  • Facilitation and Leadership skills.

Manager, Quality Operations - (Assurance – Control - Operations)

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.

Immucor offers a comprehensive benefits package available on the start date of your employment, including:

  • Medical, prescription, dental, and vision insurance – we offer multiple plan options so you can determine which best suits your needs and the needs of your dependents

  • Wellness program

  • STD/LTD/Life insurance all 100% company paid

  • Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents

  • Tuition reimbursement

  • Company matched 401k plan

  • Vacation/Company & Personal Holidays/Sick days

Where permitted by applicable law, must have received at least the first COVID-19 vaccine by the date of hire and be willing to receive the final vaccine within no more than 30 days following hire date to be considered for U.S.-based job, if not currently employed by Immucor, Inc. Proof of vaccination status will be required on first day of employment.

Job Locations US-GA-Norcross

Job ID 2021-2765

Category Management


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