Job Description Summary

As directed by the Quality Manager, the Senior Quality Engineer is accountable for Quality Assurance in the manufacturing area by developing and maintaining quality control plans, dealing with non-conforming material, customer complaints, remediation projects, CAPAs and providing quality metrics to manufacturing and quality management. This position assures the manufacturing areas are compliant to medical device regulations, good manufacturing practices, and leads continuous improvement activities for improved quality and production.

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. 

Responsibilities

• Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods/plans, work instructions, and raw material specifications.  

• Analyze and interpret inspection and process data to identify continuous improvement opportunities and prevent quality problems.  

• Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material.  

• Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.  

• Support manufacturing and quality process improvement projects as an effective team member or leader using continuous improvement and six sigma tools.  

• Develop working knowledge of applicable regulatory, corporate and unit requirements.  

• Facilitate change control, as needed.  

• Conduct internal audits as required.  Provide audit support for customer and regulatory audits (preparation, closure, etc.).  

• Communicate across functions and departments for assigned areas of responsibility.  

• Analyze and verify the consistency of existing products through annual product review.  

• Perform manufacturing investigations for out-of-specification / out-of-trend investigation for product release. 

• Writes and leads risk management activities.  

• May perform other duties as required.  

Education and Experience  

This position requires: 

• Bachelor’s degree in engineering or a scientific field with a minimum of 3 years relevant experience or 8 years of a combination of equivalent education and relevant experience.  

Preferred qualifications include: 

• Leadership, project management, and sophisticated communication skills  

• Automated high-volume manufacturing experience  

• Extrusion process for medical devices experience (plus)  

• Training in design of experiments and statistics  

• Knowledge of design control principles 

• Knowledge of six sigma methodolog