Quality Engineer IV # 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