Company: Katalyst HealthCares & Life Sciences
Location: Redwood City
Posted on: May 26, 2023
- Perform process documentation line audit/walkthrough/assessment
for each MPI/QI/WI
- Identify, review, and update Equipment gaps and qualification
- Review Forms for accuracy and identify improvements
- Identify, review, and update process MPI/QI/WI gaps related to
Practice vs Procedure
- Review and/or Create process validation protocols, process
optimization studies, and generate verification/validation
- Identify and create control plans within the manufacturing
process (i.e. daily power reading, power measurement method
- Review and/or update IQ/OQ/PQ for equipment/s that require
- Provide support to day-to-day manufacturing activities (as
needed) related to NCMR, Process
- Deviations, Drawings, manufacturing documents, in process and
final inspection, testing etc..
- Escalate issues to cross functional team as appropriate
- Bring process improvement ideas and drive solutions to
- Work cross-functionally with production, quality, R&D
- Maintain trained status for, and comply with, all relevant
aspects of the Quality Management
- System to ensure product and support regulatory compliance
- Understand and adhere to the EHS policy QUALIFICATIONS
(Education, Experience, Certifications)
- To perform this job successfully, an individual must be able to
perform each essential duty satisfactorily.
- The requirements listed below are representative of the
knowledge, skill, and/or ability required.
- Reasonable accommodations may be made to enable individuals
with disabilities to perform the essential functions.
- BS in Mechanical Engineering, Mechatronics, STEM or Quality
related education or a similar engineering discipline required,
Master's degree preferred.
- At least 5+ years of progressive experience in medical device
quality engineering, manufacturing.
- Working knowledge of 21CFR 820, ISO13485, EU-MDR requirements
for medical device manufacturers.
- ASQ CQE, CQA certification a plus
- Demonstrated reasoning ability to apply principles of logical
or scientific and critical thinking to a wide range of intellectual
and practical problems
Keywords: Katalyst HealthCares & Life Sciences, Redwood City , Quality Engineer, Engineering , Redwood City, California
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