Quality Engineer IV # JN -072021-66494
Menlo Park, California
Posted on: July 2, 2021
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