NewOrleansRecruiter Since 2001
the smart solution for New Orleans jobs

Director, Quality Assurance

Company: Abbott Laboratories
Location: Gretna
Posted on: April 9, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions. Abbott's life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people. Our location in Gretna, LA currently has an opportunity for a Quality Assurance Director. The role is responsible for the implementation, maintenance and continuous improvement of the laboratory Quality Management System and for ensuring that laboratory testing is performed in compliance with all applicable regulations and certifications, including, but not limited to, CAP, SAMHSA, and CLIA. The role requires a dynamic and self-motivated professional with demonstrated ability to influence change. Mastery of data necessary to influence fact and risk-based decisions and to demonstrate measured outcomes is a key requirement of the role. This role will be instrumental in providing quality results to our clients. RESPONSIBILITIES:

  • Develop, implement and maintain laboratory quality processes and procedures, in compliance with applicable laboratory regulations and ARDx policies.
  • Develop mechanisms to identify compliance gaps and facilitate remediation activities where necessary utilizing risk-based prioritization.
  • Regularly report on quality and regulatory performance, including trending and analysis of deviations and non-conformance, to inform laboratory quality objectives, priorities, and improvements.
  • Keep abreast of new or changing quality and regulatory practices and standards within the industry and coordinate development of or update laboratory compliance standards, guidelines and programs as appropriate.
  • Support or participate in internal, client and regulatory agency audits to ensure compliance with certification requirements, laws, regulations, policies and procedures. Includes routine audit of laboratory departments for compliance with company quality policy and procedure and CLIA, and State requirements where applicable.
  • Carries out duties in compliance with established BU and AQR practices, policies, and processes.
  • Provides subject matter expertise to drive improvements and decisions relating to quality management systems.
  • Leverages quality metrics to identify risks for the organization in order to direct and support development/implementation of policy, procedure, training, and other available tools for reducing identified risks.
  • Direct and perform internal and external audits related to regulatory, accreditation agencies and business partners. Demonstrate ability to maintain excellent positive relationships with auditors or regulatory agencies.
  • Administer and manage the document control system, Nonconformance/CAPA and incident reporting systems.
  • Ensure that Quality Assessment programs are established and maintained to identify failures in quality as they occur.
  • Assist with development, implementation and maintenance of effective departmental QA programs and monitors.
  • Assure that QA reviews are effective at identifying and preventing errors, and that corrective actions are followed up for effectiveness.
  • Review all laboratory procedures and validation documentation for compliance following regulation and guidance.
  • Monthly patient test management responsibilities include randomly selecting specimens for review of all external and internal COC, specimen label and test data records associated with these specimens including specimen reports (Tox2 and web) to ensure proper handling of patient specimens and test data.
  • Oversee and manage quality system related meetings, including quarterly management reviews, and collect and trend key performance indicators.
  • Review, report and action key quality metrics on routine basis including, but not limited to, Problem Specimens Log, Percent Positive Report, Audit Reports, CAPA and Nonconformance data, etc.
  • Address quality concerns raised by customers or identified internally, through administration and oversight of the Nonconformance/CAPA and audit programs.
  • Carries out duties in compliance with established business policies.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  • Performs other duties and projects as assigned.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities. MINIMUM QUALIFICATIONS - EDUCATION/EXPERIENCE:
    • Education BA/BS Degree in Chemistry, Biology/Medical Technology/Life Scientific related degree
    • 7 or more years in a Quality/Regulatory environment, with proven experience developing Quality Management System and audit management consistent with ISO 17025, ISO 13485 or 21 CFR 820 requirements
    • Demonstrated experience in quality systems and regulatory compliance
    • 5 or more years of experience with people management/leadership PREFERRED QUALIFICATIONS:
      • Professional certification is preferred (i.e. CQA, Six Sigma, CQM)
      • Laboratory testing & service setting
      • Must have a strategic perspective and be capable of synthesizing information and prior experience from multiple sources to build efficient and successful quality strategies for the organization.
      • Knowledge of 1988 Clinical Laboratory Amendments (CLIA '88) - federal certification requirements and State, Federal Accrediting Agency standards.
      • Must be skilled in interpreting regulatory agency requirements and to converting these into practical and pragmatic actions.
      • Must work effectively in a cross-functional environment, achieving regulatory compliance though teamwork, facilitation and influence.
      • Must have demonstrated written and verbal communication skills, including ability to articulate complex regulatory/quality arguments with clarity.
      • Must be well organized and attentive to detail, strong interpersonal skills and capable of providing support and direction to others. LEARN MORE ABOUT OUR BENEFITS THAT ADD REAL VALUE TO YOUR LIFE TO HELP YOU LIVE FULLY: WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:
        • Training and career development, with onboarding programs for new employees and tuition assistance
        • Financial security through competitive compensation, incentives and retirement plans
        • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
        • Paid time off
        • 401(k) retirement savings with a generous company match
        • The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at and on

Keywords: Abbott Laboratories, New Orleans , Director, Quality Assurance, Executive , Gretna, Louisiana

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Assistant Construction Division Manager
Description: Summary Directs activities of workers concerned with implementing construction projects by performing the following duties personally or through subordinate supervisors.Essential Duties and Responsibilities (more...)
Company: Rotolo Consultants, Inc.
Location: Slidell
Posted on: 04/18/2021

Clinical Director-Cath/EP Lab
Description: Clinical Director- Cath/EP Lab Magee Resource Group has partnered
Company: Magee Resource Group
Location: Lettsworth
Posted on: 04/18/2021

Shift Supervisor Management Trainee
Description: CVS Health - 6502 Highway 182 Retail Shift Manager As a Shift
Company: CVS Health
Location: Morgan City
Posted on: 04/18/2021

Industrial Services Project Manager
Description: Industrial Services Project ManagerLocation: Baton Rouge, LA, United StatesDate Posted: Apr 12, 2021Category: Project MgmtJob ID: 72507Job DescriptionResponsibilitiesJob Description:The Project Manager (more...)
Company: Clean Harbors Environmental Services
Location: Baton Rouge
Posted on: 04/18/2021

Assistant General Manager
Description: Assistant General Manager at Skrimp Shack - Harrisonburg, Harrisonburg, VA - ZippyApp ul li Job Seekers li Employers li Jobs li Help li Register li Login English - Espa--ol Job Seekers (more...)
Company: ZippyApp - Recruitment Marketing
Location: Harrisonburg
Posted on: 04/18/2021

Pizza Artista - General Manager - (Baton Rouge) - Great pay, Bonus & Incentives! (2)
Description: The Pizza Artista Promise...We Delight Every Guest, because we care--- Pizza Artista is a Louisiana-based company, born out of a passion to provide world-class food and hospitality. We treat our workers (more...)
Company: Pizza Artista
Location: Baker
Posted on: 04/18/2021

Tax Director
Description: Location: Baton Rouge or New Orleans Our client, an Accounting and Finance firm, in Baton Rouge is looking for a Tax Director to join their team FULL TIME. This opportunity will start in March, or when (more...)
Company: VC5 Consulting
Location: Baton Rouge
Posted on: 04/18/2021

Account Manager
Description: Design your life of financial freedom and flexibility. Run your own agency with uncapped commissions and a flexible schedule under one of the largest and most-respected insurance brands in the United (more...)
Company: Colonial Life
Location: New Orleans
Posted on: 04/18/2021

SAP S/4 Credit Management
Description: View all jobs SAP S/4 Credit Management Baton Rouge, LA -- Information Technology Required Skills: br Need to have
Company: RESOURCE1
Location: Baton Rouge
Posted on: 04/18/2021

RN Manager Iberville
Description: Job DescriptionThis job assumes unit responsibility for the practice, quality of care, and service delivered, provides leadership and support to encourage the optimum development and performance of staff (more...)
Company: Ochsner Health
Location: Plaquemine
Posted on: 04/18/2021

Log In or Create An Account

Get the latest Louisiana jobs by following @recnetLA on Twitter!

New Orleans RSS job feeds