Job Description Summary

The facility QA Manager has the responsibility of leading the Quality Assurance Department and ensuring compliance to regulations, national and international standards, specifications and Corporate, Segment, Business Unit and internal policies and procedures. This includes the responsibility to lead a department of trained quality employees and to provide them with the tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional development for success. The QA Manager will also support Divisional business activities including new product and business development initiatives.

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 / Key Job Responsibilities (including supervisory and/or fiscal):

• Coordinate the efforts of the staff functions with those of other departments in Carol Stream​​

• Participate in Quality System and Safety audits as required. Lead efforts to implement corrective actions and recommendations. 

• Lead a quality staff to ensure proper implementation and maintenance of a quality system in compliance with the Quality System Regulation, ISO 13485, National and International Standards, product specifications and Corporate, Segment, Business Unit and Internal policies and procedures. 

• Lead FDA & ISO Audits of the Carol Stream Facility 

• Lead management reviews for facility and lead continuous improvements projects. 

• Establish tracking and trending of quality indicators. Develop quality indicators to enhance quality of products and business performance. 

• Act as facility regulatory representative as delegated. 

• Create, review, and approve quality system programs and documents (CAPA’s, NCMR’s, SA’s, Quality Plans, Risk Assessments, etc.)  

• Establish quality plans to ensure that products conform to specifications. 

• Provide technical support for complaint review and investigation.