Staff Quality Engineer

Becton Dickinson Medical Devices•San Diego, CA

10h•Onsite

About The Position

Support new product development and product maintenance through the application of Quality engineering skills for medical devices. Support projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Participate in design control meetings and provides feedback regarding product quality. Works closely with engineering, manufacturing, purchasing, marketing, technical service, and regulatory affairs on quality issues. Review non-conformances identified by suppliers and manufacturing facilities; assess impact on product quality; and communicate findings and recommendations to appropriate personnel. Develop test methods and sampling plans. Design experiments; collect data; analyze results; prepare reports; present findings and make recommendations based on analysis of data. Write and interpret technical documents such as drawings, specifications, operating procedures, and Form 483 observations. Participate in FDA (Food and Drug Administration) inspections; coordinate Notified Body audits; and conducts internal audits as directed. Support product launches by working with production, quality assurance, regulatory affairs, technical service, and shipping/receiving to ensure successful transition from development to full scale manufacturing. Conduct root cause investigations of product complaints and quality issues; initiate corrective actions; monitor implementation and effectiveness of corrective actions.

Requirements

Master’s degree in Engineering (any) or related field of study and two (2) years of work experience in the job offered or related occupation in which the required experience was gained.
In lieu of a Master’s degree in Engineering (any) or related field of study and two (2) years of work experience in the job offered or related occupation in which the required experience was gained, employer will also accept a Bachelor’s degree in Engineering (any) or related field of study and five (5) years of work experience in the job offered or related occupation in which the required experience was gained.
Demonstrated experience in Statistical analysis and quality tools.
Demonstrated experience in Medical device design controls (21 CFR Part 820.30), ISO 13485, and risk management (ISO 14971).
Demonstrated experience in Quality tools and methodologies such as: FMEA, SPC and Root Cause Analysis.
Demonstrated experience with Software tools: TeamCenter, Polarion, AzureDevOps or PLM systems.
Demonstrated experience in Assessing design changes for impact on product requirements and specifications.
Demonstrated experience in Linking product level changes to requirements and specifications, and providing an engineering assessment on whether these changes require re-verification or validation.
Demonstrated experience in Analyzing technical data to use in place of functional testing as a form of verification using statistical techniques, electrical engineering, mechanical engineering, and material science to offset testing with analysis.
Demonstrated experience in Investigation techniques to support CAPAs, as well as the software tool in which to document these investigations (trackwise).

Responsibilities

Support new product development and product maintenance through the application of Quality engineering skills for medical devices.
Support projects and tasks, from product inception through product launch and maintenance.
Ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Participate in design control meetings and provides feedback regarding product quality.
Works closely with engineering, manufacturing, purchasing, marketing, technical service, and regulatory affairs on quality issues.
Review non-conformances identified by suppliers and manufacturing facilities; assess impact on product quality; and communicate findings and recommendations to appropriate personnel.
Develop test methods and sampling plans.
Design experiments; collect data; analyze results; prepare reports; present findings and make recommendations based on analysis of data.
Write and interpret technical documents such as drawings, specifications, operating procedures, and Form 483 observations.
Participate in FDA (Food and Drug Administration) inspections; coordinate Notified Body audits; and conducts internal audits as directed.
Support product launches by working with production, quality assurance, regulatory affairs, technical service, and shipping/receiving to ensure successful transition from development to full scale manufacturing.
Conduct root cause investigations of product complaints and quality issues; initiate corrective actions; monitor implementation and effectiveness of corrective actions.