Overview
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 innovate across the full spectrum of healthcare solutions to deliver breakthroughs of tomorrow and impact health for humanity. Learn more at https://www.jnj.com
job function: quality
job sub function: quality assurance
job category: people leader
all job posting locations: ciudad juarez, chihuahua, mexico; juarez, chihuahua, mexico
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. Are you passionate about improving and expanding the possibilities of cardiovascular? Ready to join a team that’s reimagining how we heal? Our cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a heritage of elevating standards of care for stroke, heart failure and atrial fibrillation (afib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
an internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
quality operations manager – purpose
plans, coordinates, and directs the quality assurance programs designed to ensure the continuous production is consistent with the established standards, through responsibilities either personally or through subordinates.
you will be responsible for
* business improvement: lead or support quality improvement initiatives and characterize processes and products to drive continuous improvement and cost reduction.
* assessment of methods: revise/analyze effectiveness of pdca, six sigma, kaizen, lean techniques and other tools.
* benchmarking: perform benchmarking to develop more effective quality methods.
* quality metrics: establish and formulate quality metrics aligned with plant objectives.
* quality engineering and lifecycle: support development of quality engineering and lifecycle management for new products.
* quality projects: promote and support quality, product, and process improvement projects.
* ecos: review and approve engineering change orders (ecos).
* quality costs: monitor and analyze quality costs to maintain a compliant quality system per medical industry standards.
compliance / regulatory
* ensure current products and processes comply with regulations (qsrs, iso 13485, etc.).
* lead regulatory audit preparations as sme or escort (fda, jjrc, bsi, etc.).
* respond to audit observations to ensure compliance with procedures and regulations.
* maintain required documentation of quality assurance activities and quality systems.
* perform periodic line audits to evaluate gmps, production controls, lot segregation, and process audits; ensure corrective and preventive actions are adequate.
finances
* define, monitor, and administer the department budget.
new products / process introduction
* collaborate with npi, operations, and engineering to develop, conduct, and approve validation strategies of products and processes.
product quality, control and disposition, and performance standards
* direct and attend nc revision meetings as mrb member.
* review investigations, capas, customer complaints, non-conformities, and escalation of quality problems as applicable.
* identify materials, segregation, and defect classifications; apply these in day-to-day manufacturing.
* provide direction and resources to resolve complex manufacturing process problems at local or franchise level.
product grading / process
* approve process validation strategies.
* ensure periodic maintenance and review of ctqs, pfmeas, quality control plans, and process instructions.
* support process monitoring/control methods appropriate to risk level.
* promote innovative tools for risk detection and mitigation; assess effectiveness of improvements.
* own risk assessment, including fmea, for changes in product/process.
strategy
* identify required quality engineering skills to enable strategic vision; plan with site leaders and product engineering teams; set priorities and allocate resources.
people
* supervision, mentoring, performance reviews, development plans, and succession planning as applicable.
* communicate business issues/opportunities to management; ensure adherence to health, safety, and environmental guidelines; ensure resources are available and in good condition.
qualifications / requirements
* bachelor’s degree in engineering (mechanical, electrical, industrial or related); master/doctorate preferred.
* 8–10 years of work experience or demonstrated performance.
* proficiency with computer software; ability to interact with governmental/auditing agencies.
* excellent english communication skills (spoken and written).
* strong problem-solving and negotiation abilities.
* certifications such as cqa, cqe, cqm (preferred), cba, mbb, or bb are a plus.
seniority level
* not applicable
employment type
* full-time
industries
* hospitals and health care
referrals increase your chances of interviewing at johnson & johnson medtech by 2x
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