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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.
Job function
quality
job sub function
quality assurance
job category
people leader
all job posting locations
ciudad juarez, chihuahua, mexico
job description
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.
Diversity, equity & 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.
Purpose
the quality assurance supervisor manages quality auditor associates to comply with product release schedule program in accordance with the quality system, while ensuring that health, safety and environmental requirements and company policies are used effectively and efficiently. The quality assurance supervisor plans or adapts new methods or procedures to control or coordinate the qa role across several projects simultaneously and resolves technical projects. The holder of the position will also use quality engineering principles and investigative skills for resolution of complex problems and will apply appropriate risk management to prevent unforeseen failure modes and improve process capacity.
You will be responsible for
product quality, control and disposition and performance standards
provide leadership and technical knowledge for daily quality assurance, ensuring established metrics are met.
Provide supervision, mentoring, coaching, performance revision, development plans and succession planning for others (when applicable).
Conduct or support investigations, bounding, documentation, revision and approval of non-conformities (ncs), preventive and corrective actions (capas), customer complaints and escalation of quality problems when applicable.
Own identification of material, segregation, classification of defect types, applying these techniques day‑to‑day in manufacturing.
Define sampling plans and approve inspection methods for evaluation and acceptance of components and finished product.
Support resolution of complex technical problems associated with manufacturing at a local or franchise level.
Product grading / process
develop, maintain and verify measurement methods appropriate for the manufacturing process.
Develop, interpret and implement process monitoring and control methods consistent with the risk level of the process/product.
Evaluate the need for risk mitigation techniques due to product classification, defect types, severity, patient risk, process capacity and controls.
Business improvement
revise/analysis of effectiveness of pdca, six sigma, kaizen, lean techniques and other improvement tools and programs.
Perform benchmarking to develop more effective methods to improve quality.
Establish metrics that are quality indicators.
Compliance/regulatory
revisit/analyze if current products and processes comply with qsr, iso 13485, etc., and provide support during internal and external audits.
Participate in preparation and interaction with regulatory agencies (fda, jjrc, bsi, etc.).
Respond to internal or external audit observations related to the qa function.
Establish and maintain required documentation of qa activities and/or quality systems.
Perform periodic audits in the line to evaluate gmps, production controls, lot segregation and processes according to jjps, revising audit results to ensure corrective/preventive actions are adequate.
Strategy
collaborate with quality leaders to identify required quality engineering skills and competencies that support strategic vision.
General
communicate business‑related issues or opportunities to next management level.
Ensure adherence to all company guidelines related to health, safety and environmental practices.
For supervisors or managers, ensure subordinates follow all health, safety and environmental guidelines and have necessary resources.
Ensure personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
Perform other duties as assigned.
Qualifications
at a minimum, a bachelor’s degree, preferably in engineering: mechanical, electrical, industrial, or applied sciences.
6 to 8 years of work experience or a proven track record.
Experience in the medical device industry or in the medical field, preferably.
Experience with software packages.
Ability to communicate in english, both orally and in writing.
Knowledge of product/process risk management (fda and iso regulations), preferably.
Advanced technical training and experience in statistics and lean and six sigma methodologies, including msa, spc, does, reliability, etc.
Active participation in problem solving and troubleshooting, preferably.
Problem‑solving and good judgment, highly desirable.
Demonstrated project management and project leadership skills, preferably.
Certifications such as cqa and cqe (preferably), cba and green belt are a plus.
Required skills
business savvy, compliance management, corrective and preventive action (capa), cross‑functional collaboration, developing others, fact‑based decision making, give feedback, human‑centered design, inclusive leadership, iso 9001, leadership, quality control (qc), quality management systems (qms), quality standards, risk assessments, standard operating procedure (sop), team management.
Preferred skills
business savvy, compliance management, corrective and preventive action (capa), cross‑functional collaboration, developing others, fact‑based decision making, give feedback, human‑centered design, inclusive leadership, iso 9001, leadership, quality control (qc), quality management systems (qms), quality standards, risk assessments, standard operating procedure (sop), team management.
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