Quality Supplier Engineer

Job Title Quality Supplier Engineer

Location Irvine CA

Job Description:

Quality Management ISO 13485 Medical Device Regulatory Standards Quality Compliance CAPA / NC Windchill PLM system.

EIS : Medical Device & Regulations

46

• Quality Engineer A minimum with 5 years of related experience Quality Management in Medical Device Industry

• Knowledge of Medical procedure and corresponding Medical Equipment
• Knowledge of Medical Equipment manufacturing processes
• Knowledge on Quality Management and its tools & techniques
• Knowledge about FDA ISO 13485 ISO 14971 and compliance regulations
• Knowledge on Medical Device Regulatory Standards MDD and MDR
• Knowledge on NC CAPA Audit processes
• Knowledge in Statistic Risk Management and Design control
• Must possess good communication skills (verbal and written) familiar with project management methodology problem solving and presentation skills

• Under limited supervision and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines the duties and responsibilities for this position are:
• Working with other functional groups including R&D and Operations in support of new product development engineering projects quality assurance activities and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development transfer and maintenance of products/processes throughout the product lifecycle. Support Windchill migration activities.
• Provide User Trainings on the Windchill.
• Oversight from a Quality NPD perspective of the NonConformance Report (NCR) process for BWI facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans AFMEA DFMEA and PFMEA.
• Write review and/or approve process and product validation protocols and reports equipment qualifications engineering change orders.
• Use statistical tools to analyze data make acceptance decisions and improve process capability (Six Sigma Statistical Process Control (SPC) Design of Experiments (DOE) etc.).
• Performs statistical analysis of data generated including but not limited to: Gauge R&R ANOVA Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
• Ensure that development activities follow design control requirements (Design Trace Matrix) product is tested per applicable standards GSPR are met per the MDR and product is properly transferred to manufacturing per applicable specifications.
• Technical problem solving failure analysis and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Recommend issue resolution to management for significant capability and compliance issues.
• Works closely with functional leadership in planning and executing project milestones.
• Plans develops coordinates and directs one or more large important engineering projects or a number of small projects with many complex features.
• Carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
• Assesses the feasibility and soundness of proposed engineering evaluation tests products or equipment when necessary data are insufficient or confirmation by testing is advisable.
• Responsible for communicating business related issues or opportunities to next management levels.
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
• Performs other duties assigned as needed.