Overview
Quality Engineer III/Sr. Quality Engineer Jobs in Redwood City, California, USA at LanceSoft
Position: Quality Engineer III / Sr. Quality Engineer
Company Description
JOHNSON & JOHNSON / CALIBRA
Job Description
** Sr. Quality Engineer for Swing Shift
QA Manager
Redwood City, CA
Purpose of *
Supports production of clinical devices and process development. Maintains compliance to Medical Device Directives (MDD), ISO 13485, and Quality System Regulations for Design Controls. Create protocols and reports for a device manufacturing and testing where needed. Perform specific data analysis and trending as required. Provide technical support to Manufacturing and R&D.
Essential *
Assists in assuring that Good Manufacturing Practice requirements are met, including Design Control.
Performs review of production LHR and signoff as required.
Reviews currently manufacturing process documentation and records.
Works with Quality and Operations to maintain quality requirements in the support of clinical builds.
Develops and implements specific testing for existing and new products including supporting process validations.
Provides support to manufacturing inspection process development.
Researches and provides guidance to the design team regarding standards and regulations applicable to the development project.
Perform other duties in quality assurance as directed.
Works in accordance with quality system procedures.
Minimum *
* BS/BA in an Engineering discipline preferred, equivalent combination of education and work experience acceptable.
5 years of experience in Quality Engineering in the medical device industry.
Licenses, Certifications, and **ASQ Certified Quality Engineer certification preferred.
Other Essential Knowledge, Skills, and *
Must have strong oral and written communication skills.
Strong knowledge in the use of manufacturing processes used in the medical device industry.
Strong knowledge of statistical data analysis.
Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO
14971.
Working *
Job duties are typically performed in an office environment. Overall duties require the ability to stand or sit for lengthy periods of time in a lab. Required duties include utilizing standard office equipment such as a computer, photocopier, and telephone, and reading and writing.
* Some out of town travel may be required for supplier interactions (anticipated to be 10% of time)
Personal Protective **
Latex/rubber/heat resistant gloves, UV eye protection, safety glasses, goggles, respirators, splash aprons, cleanroom gowning wear (smocks, head covers, beard covers, shoes covers).
J-18808-Ljbffr
Title: Quality Engineer III/Sr. Quality Engineer
Company: LanceSoft
Location: Redwood City, California, USA
Category: Engineering, Quality Assurance – QA/QC
