At johnson & johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.
Diversity & inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, you are welcome in all open positions at the largest healthcare company in the world.
When you join johnson & johnson, your move could mean our next breakthrough.
We are searching for the best talent for *senior compliance technician for maintenance and calibration *to be in *ciudad juarez *.
*job summary*
support on planned and unplanned audits, verifying compliance with government regulations and applicable standards, in addition to company policies and procedures. Provides support during the preparation and execution of internal and external audits. Responsible to elaborate metrics with kpis by quality system. Prepare pre-requisites, organizes information, and follow up actions generated as part of the internal and external audits for maintenance and calibration department.
If it is a css position: this position will have responsibilities across ethicon and cardiovascular and specialty solutions (css) companies (johnson and johnson family of companies) including a range of multiple product platforms such as general surgical devices, sutures, ent, prevention of infection, electrophysiology and surgical and non-surgical aesthetics.
*duties & responsibilities*
under limited supervision and in accordance with all applicable federal, state and local laws/regulations and corporate johnson & johnson, procedures and guidelines, this position:
- conducts internal periodic review for maintenance and calibration reports/certificates.
- conducts good laboratory practice (glp) as required.
- gives guidance or advice to maintenance and calibration personnel regarding compliance with applicable standards and regulations.
- follows action plans, effective monitoring, and investigations as result per quality systems audits, non-conformances, capas and related.
- occasionally leads audits as sme of calibration and maintenance department.
- keeps changes through publications, participation in seminars or through collaboration with organizations abreast of applicable standards for maintenance and calibration department.
- interprets maintenance and calibration records.
- domain maintenance, calibration and maximo system procedures.
- follows good manufacturing practices procedures (gmps) and good documenting practices (gdps)
- applies the regulations stated by the metrology international standards such as iso 17025, iso 10012, guide 25, ansi and others.
- responsible for communicating business related issues or opportunities to next management level.
- for those who supervise or manage a staff, responsible for ensuring that subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition, if applicable
- responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures
- performs other duties assigned as needed.
*qualifications*:
*experience and education*
*education*:
technical studies: electromechanical, instrumentalist, maintenance related field. Bachelor’s degree in engineering or related areas (desirable)
*expertise*:
- minimum 5 years of experience with standards regulations related to instrumentation, metrology, calibration, maintenance, and others (desirable)
- experience required on service, maintenance, equipment/process engineering, areas around manufacturing site with gmp products.
- ability to communicate complex situations in simple terms.
- anticipates and appropriately handles conflict situations.
- leads implementation of solutions to complex situations or problems.
*required knowledge, skills, abilities, certifications/licenses and affiliations*
- effective communication skills - oral and written - (english and spanish)
- analytical skills to interpret scientific and technical publications as legal documents also.
- skills to present information effectively to senior management and public groups.
- skills for the use of computers and associated systems (software, e.g., ms office).
- skills to interact with auditors by the government and independents.
- knowledge in problem-solving techniques.
- advanced knowledge of metrology international regulations.
- reading and interpretation of mechanical and electrical blueprints (desirable).
- knowledge on statistical tools and data analysis for interpretation is mostly preferred.
- knowledge of microsoft office (word, excel, powerpoint, outlook) is required as well as minitab, ecmms, etq compliance system etc.
- knowled