Quality Engineer

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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.

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.

Must also have demonstrated experience in the following:
Statistical analysis and quality tools;
Medical device design controls (21 CFR Part 820.30), ISO 13485, and risk management (ISO 14971);
Quality tools and methodologies such as: FMEA, SPC and Root Cause Analysis;
Software tools:
Team Center, Polarion, Azure Dev Ops  or PLM systems;
Assessing design changes for impact on product requirements and specifications;
Linking product level changes to requirements and specifications, and providing an engineering assessment on whether these changes require re-verification or validation;
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; and Investigation techniques to support CAPAs, as well as the software tool in which to document these investigations (trackwise).

Salary offered for the position is: $ - $/year.

Primary

Work Location:

3750 Torrey…