This job board retrieves part of its jobs from: Toronto Jobs | Emplois Montréal | IT Jobs Canada

Find jobs in California today!

To post a job, login or create an account |  Post a Job

  Jobs in California  

Bringing the best, highest paying job offers near you

previous arrow
next arrow

Quality Engineer with medical device

HCL Technologies

This is a Full-time position in Irvine, CA posted February 11, 2021.

nn nn nnThis position is responsible for identifying and coordinating process improvement initiatives, including best practices and standard operating procedures.

The role is responsible for identifying, planning and implementing key projects to improve quality, reduce cost, increase productivity and improve cycle time, resulting in significant business improvement and customer satisfaction.nn nn n nn nn Process Optimization and development experience.nn nn Continuous improvement tools and techniques to measure and improve the process.nn nn Six sigma methodologies, Machine design experiencenn nn Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.nn nn Support Doc Center activities for document processing, batch release and training.nn nn Escalates issues to supervisor/manager for resolution, as deemed necessary.nn nn Experience with ISO13485, 21 CFR 820, EU MDR and other regulatory requirements associated with medical devices.

nn nn Experience working with Management Review, QMS Risk Management and Change Control processesnn nn Experience with TrackWise, Agile PLM and Agile MAP softwarenn nn Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.nn nn Strong technical writing and documentation review skills nn nn Strong critical thinking and analytical skillsnn nn n nn nn Skills set: Process validation (IQ, OQ, and PQ), CAPA, NCMR/ NCR, TMV, Kaizen, Process improvement, Six sigmann nn n nn nn Mandatory Skills: Medical Device Packaging Design Change Assessment, Verifications and validations, CAPA, NCMR/NCR analysis and reports, Process validationnn nn n nn nn Desired Skills: Verification and Validation, ISO 13485 Medical Device Quality Management system, Risk Management ISO14971, Minitabnn nnby Jobblenn

AL Jobs AR Jobs CA Jobs GA Jobs KS Jobs KY Jobs LA Jobs MD Jobs MI Jobs MN Jobs MS Jobs MO Jobs NY Jobs OR Jobs TN Jobs TX Jobs UT Jobs VA Jobs WV Jobs ID Jobs