Job Description Summary

Job Description

We are the makers of possible 

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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

ESSENTIAL FUNCTIONS OF THE POSITION 

• Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards that meet the needs of the business. 

• Provides technical and quality support to suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of product returned from the field. 

• Investigates product complaints and directs the activities required to assure the timely implementation and documentation of corrective action. 

• Provides support and assures QSR compliance in product and process validations and product and process transfers. 

• Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendations in a timely manner. 

• Prepares for and participates in internal and external audits and implements corrective action to audit observations to prevent recurrence. 

• Participates in the Material Review Board meetings and takes the lead with other functional groups to determine root cause failure and implement actions to prevent recurrence. 

• Supports operational teams responsible for investigating and providing corrective action for NCRs and/or CAPAs. 

• Serves as Quality representative for design transfers or technology transfers. 

• Lead the development of Process FMEAs. 

• Leads Quality Engineering Projects to improve Quality System and Procedures (e.g., defect analysis, control charts, data analysis, lead Quality and Continuous Improvement Projects). 

• Develops or assists in the development of Process Validation documentation such as protocols and reports (IQ, OQ, PQ) and performs statistical analysis as required. 

• Performs test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices. 

• Performs special projects and other duties as assigned. 

QUALIFICATION GUIDELINES 

• B.S. Degree in Engineering or Technical Science.

• Prior experience as a quality engineer lead on new product development teams.

• Relevant medical device experience. 

• Applied Knowledge of the requirements of FDA QSR, ISO13485 and ISO 14971:2012. 

• Experience in Quality Engineering disciplines including product/ process validation, applied statistics, and technical problem solving.   

• ASQ CQE certification preferred. 

• Experience with combination products and absorbable technologies preferred.  

• A high level of compe