Director, Quality Assurance
Company: Abbott Laboratories
Posted on: April 9, 2021
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
- 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
- Regularly report on quality and regulatory performance,
including trending and analysis of deviations and non-conformance,
to inform laboratory quality objectives, priorities, and
- 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
- 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
- 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
- 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,
- 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
- Demonstrates commitment to the development, implementation and
effectiveness of Quality Management System per ISO, FDA, and other
- 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
- 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
- Demonstrated experience in quality systems and regulatory
- 5 or more years of experience with people management/leadership
- Professional certification is preferred (i.e. CQA, Six Sigma,
- 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
- Knowledge of 1988 Clinical Laboratory Amendments (CLIA '88) -
federal certification requirements and State, Federal Accrediting
- 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
- 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
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