Quality Engineer IV # JN -072021-66494

Menlo Park, California
Industry: QA Testers
Job Number: JN -072021-66494

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
  • The engineer will be based in Menlo Park, CA but will also support the Fremont, CA site

 

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

 

Location: 

  • Menlo Park, CA

 

Education:

  • Bachelor’s degree in engineering or related discipline

 

Experience:

  • 2-5 years in the medical device or related industry

 

Competences:

  • Need to be able to make sound decisions with attention to details
  • Understanding the impact of regulatory requirements (eg. GMP’s, ISO 13485, ISO 14971, and MDD) on Organization’s products is necessary
  • Must be able to provide and implement solutions to quality problems
  • Ability to plan and schedule multiple projects and tasks
  • Effective written/oral communication skills
  • Team player
  • MS Office, MS Excel, and Statistical software proficiency

 

Physical Demands:

  • Weightlifting: Light (0kg - 5kg)
  • Position: Mostly sitting
  • Repetitive Motion: Mostly computer use
  • Chemical Exposure: No chemical exposure or cleaning.
  • Physical Risk (Personal Protective Equipment (PPE): Occasional use of PPE may be required

 



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