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Quality Engineer III

In California / United States

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Quality Engineer III   

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JOB TITLE:

Quality Engineer III

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Menlo Park California / United States

JOB DESCRIPTION:

Quality Engineer Potential to extend or convert to perm.Description:Role Overview:Manufacturing Quality Engineer will be responsible for supporting incoming, in-process and final product release inspection activities and resolution of nonconformance events. Ensure manufacturing activities are executed in compliance with Quality System requirements, FDA QSR, cGMP, ISO 13485, Canadian CMDR and other standards and regulations applicable for a device-drug combination product.Responsibilities:- (30%) Investigate, disposition and review manufacturing non-conformances reports, CAPAs, and audit findings for manufacturing related issues and recommend courses of corrective action.- (15%) Prepare metrics for NCRs, CAPAs, suppliers’ performance and analyze process data and trends to drive improvement.- (15%) Manage product complaint investigations, complaint trend analyses, and other related post market surveillance activities- (15%) Support calibration activities.- (10%) Create inspection procedures for the inspection of incoming materials, in-process materials and finished goods.- (5%) Support sterilization and environmental monitoring activities.- (5%) Interface with suppliers on supplier corrective action requests.- (5%) Review manufacturing records for labeling, and lot history records and provide final quality approval.Education:Bachelor’s degree in engineering or related disciplineLicenses/ Certifications:NoneExperience:2-5 years in the medical device or related industryCompetences:Understanding the impact of regulatory requirements (i.e.. GMPs, ISO 13485, ISO 14971 & MDD) is necessary

Position Details

POSTED:

Aug 20, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S165591000769530

LOCATION:

California / United States

CITY:

Menlo Park

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Quality Engineer III    Apply

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Quality Engineer Potential to extend or convert to perm.Description:Role Overview:Manufacturing Quality Engineer will be responsible for supporting incoming, in-process and final product release inspection activities and resolution of nonconformance events. Ensure manufacturing activities are executed in compliance with Quality System requirements, FDA QSR, cGMP, ISO 13485, Canadian CMDR and other standards and regulations applicable for a device-drug combination product.Responsibilities:- (30%) Investigate, disposition and review manufacturing non-conformances reports, CAPAs, and audit findings for manufacturing related issues and recommend courses of corrective action.- (15%) Prepare metrics for NCRs, CAPAs, suppliers’ performance and analyze process data and trends to drive improvement.- (15%) Manage product complaint investigations, complaint trend analyses, and other related post market surveillance activities- (15%) Support calibration activities.- (10%) Create inspection procedures for the inspection of incoming materials, in-process materials and finished goods.- (5%) Support sterilization and environmental monitoring activities.- (5%) Interface with suppliers on supplier corrective action requests.- (5%) Review manufacturing records for labeling, and lot history records and provide final quality approval.Education:Bachelor’s degree in engineering or related disciplineLicenses/ Certifications:NoneExperience:2-5 years in the medical device or related industryCompetences:Understanding the impact of regulatory requirements (i.e.. GMPs, ISO 13485, ISO 14971 & MDD) is necessary


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