Senior regulatory compliance analyst (technician)
at johnson & johnson, we believe health is everything.
our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
through our expertise in innovative medicine and medtech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
learn more at
job function: quality.
job sub function: quality control.
job category: business enablement/support.
company location: ciudad juarez, chihuahua, mexico.
about medtech
fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
learn more at
about cardiovascular
fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
our cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke.
you will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (afib) patients.
purpose
under supervision, supports monitoring of compliance metrics and dashboard maintenance for different forums.
also supports site internal audit program and external audit readiness activities as required.
you will be responsible for
supports monitoring of compliance metrics and dashboard maintenance to be presented in different forums.
supports the site audit readiness program, as required.
supports compliance training education programs applicable to the organization.
ensures compliance with the quality policy in all activities.
interacts with all departments and provides support to company activities as required.
provides periodic reports, completes special assignments, as assigned.
creates procedure/document changes and performs implementation tasks as applicable.
supports and promotes the safety and industrial hygiene objectives of the plant.
responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
performs a variety of other duties of a complexity commensurate with the job level as assigned or required.
follows compliance regulations and standards applicable to the organization.
knowledge of operating procedures and related computer systems required.
communicates business related issues or opportunities to the next management level.
follows all company guidelines related to health, safety and environmental practices as applicable.
performs other duties assigned as needed.
supports development of executive-level presentations for different forums with high visual content based on quality systems data.
analyzes data and trends.
provides general consultancy on the access and use of audit module system.
executes periodic reports and maintains the required databases to track the progress on the action plans and effectiveness monitoring plans raised from audit observations.
supports readiness activities for external audits, as required.
participates in site internal audit program.
qualifications / requirements
high school or technical career.
preferably graduated from an engineering degree.
from 2 to 4 years.
if bachelor degree completed, no experience required.
experience working in fda regulated environment (desirable).
good written and oral communication skills as well as report writing, presentation, and training skills both in english and spanish.
computer literate with microsoft office or similar.
accomplishes objectives in a timely manner with limited day-to-day supervision.
good interpersonal skills; customer service oriented.
working knowledge in current good manufacturing practices, data integrity and all applicable standards and regulations and respective requirements applicable for the organization (preferred).
experience as quality systems auditor (preferred).
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