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 at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Ciudad Juarez, Chihuahua, MexicoJob Description:
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. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
About Surgery
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 surgery? Ready to join a team that’s reimagining how we heal? Our
Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for SENIOR QUALITY LIFE CYCLE ENGINEER
Purpose:
The Senior Quality Life Cycle Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products, and ensures compliance to good manufacturing practices, international organization for standardization and any other applicable standards. Depending on job needs, a Senior Quality Life Cycle Engineer may work in:
New product development / new product introduction / new process introduction
Supply chain (life cycle engineering, manufacturing, assembly, or supplier quality)
Quality systems and business processes
You will be responsible for:
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Provides leadership in design and implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product
Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers
Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met
Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments.
Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.
Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions
Communicates business related issues or opportunities to next management level
Oversees audits of quality system categories to assess compliance to process excellence standards
Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings
Performs and/or oversees complex hands-on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications
Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost
Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
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 / Requirements:
A bachelor’s degree in engineering from an accredited engineering or relevant science/technical school is required. A degree in Mechanical, Electrical, or Biomedical Engineering or other equivalent technical degree is preferred.
Non-STEM graduates with follow-on technical training or experience will also be considered. Appropriate relevant advanced degrees are preferred.
Generally requires minimum of 4 years’ work experience. Experience in a regulated industry (medical technology, pharmaceutical, or biotechnology) or veterans with leadership experience will be given preference.
Experience with Risk Management (ISO 14971), Medical Device Quality Management System (ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred
Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred
An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset
Candidates must be fluent in English, for both written and oral communication
Candidate must have strong analytical problem-solving skills and be able to contribute to or lead root cause investigations using various problem solving techniques and tools, and assess effectiveness of corrective actions
Candidate must have sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment is required; ability to work cross-culturally is also highly valued
Demonstrated experience working within a team, obtaining feedback, negotiating, and positively influencing is required
Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations is required
Fundamental technical understanding of manufacturing equipment and processes is required
Prior experience working with Risk Analysis and Risk Management is also preferred
Advanced quality systems (AQS) experience preferred
Knowledge of: Regulatory compliance, GMPs, MDR (Medical Devices Regulation), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications desired
Required Skills:
Preferred Skills:
Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing