worldwide. Together, we are working to shape the future of health through differentiated products and services.
Responsibilities & Accountabilities
Continuous Improvement, Quality Assurance and Performance:
Guide the implementation of continuous improvement, through Lean, Six Sigma, Kaizen, PDCA.
Review and analyze collected data for statistical analyses and as part of process improvements and day-to-day support.
Participate and act as a mentor in root cause analysis with respect to process improvements with knowledge of 5 Whys, Fishbone, A3 Analysis.
Implement and review of Non-Conformance Reporting and CAPA.
Accountability and ownership of Quality Metrics and responsible for maintaining leading quality indicators and actioning corrections on indicators of lagging quality.
Review active corrective and preventive actions are adequate.
Provides Mentorship in Process Optimisation and process improvement initiatives as well as problem solving.
Regulatory, Standards and Compliance:
Analyze/review current product and processes for compliance with ISO 13485, QSR, EN, etc. and champion compliance to global regulations such as FDA, EUMDR, support internal and external audits.
Review corrective actions to periodic line audits in relation to compliance, to production controls and review audit findings for Non-Conformance and CAPA.
Review failure modes cause analysis for products and processes. Act as a mentor for risk management
Assess risk mitigation techniques given product classification, potential defect types, defect frequency, severity, risk, process capability, process controls, etc. Review, analyze and approve proposed changes to risk management documentation.
Analyze and review implemented process monitoring and control methods for appropriateness and consistency.
Review sampling plans.
Qualification, Validation and NPI:
Reviews and approves IQ, OQ/PQ and CSV for manufacturing and test equipment.
Ensures suitability of measurement systems through the principles of MSA and analyze, review and approve that collected data is reliable, and consistent e.g., Gauge Repeatability and Reproducibility. Ability to analyse output to aid in problem solving.
Provides mentorship on the analysis of sources of variation in measurement systems, with a view to control of variation.
Ensures effective quality strategies are carried out for the validation of test methods, process and design.
Participate and drive New Product Introduction (NPI) design transfer and establishing process stability for NPI through the review, analysis and approval of implemented statistical process control activity and monitoring of process performance.
Approval of change control of changes for compliance to established standards, regulations and procedures. Mentors team through change process.
Experience and Education
A minimum of a Bachelor's Degree, preferably in Engineering or related technical field.
4-6 years in an engineering or quality role or 2+ years in a related leadership position.
Proven track record for implementing appropriate risk mitigation.
Technical training and experience using Statistics, Lean and Six Sigma methodologies is required, i.e., Measurement System Analysis, SPC, DOEs, Reliability, etc.
Demonstrated project management and project leadership abilities are needed.
Required knowledge, skills, abilities, certification/licenses
Consistent record in "hands on" troubleshooting and problem solving.
Good technical understanding of manufacturing equipment and processes is required.
A detailed understanding of GMP, ISO Standards and FDA regulations for validation and product/process risk management is needed.
Consistent record in mentorship of others.
Demonstrated ability with respect to process improvements.
Location and Travel requirements
This position may require up to 10% travel and will be based in an MD&D manufacturing facility.
Working at Johnson & Johnson
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.