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. 

Purpose of Position:

The Sr. / Staff Quality Engineer is responsible for supporting Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform.   The incumbent works multi-functionally with teams on change management projects (including those that may impact product design), design transfers, global expansion projects, risk management, process/product design and development, quality improvement projects (QIPs), and cost to win (CTW) projects.

General Functions, Specific Responsibilities, and Authority:

The Staff Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.), as well as R&D, Manufacturing, Sales, Marketing, Operations, Supply Chain, and Finance. The Sr. / Staff Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to product change regulatory submissions and regional expansions, with DCHU on complaint handling/resolution and field actions pre-/post - product launch, Packaging COE on new product packaging projects and changes, Sterility Assurance on sterilization process (re)validations and with Platform Management regarding product design and development, as well as design transfer activities.

Product Quality and Lifecycle Management:

• Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.

• Lead Quality Engineering Projects to improve Quality systems and Procedures.

• Support or lead activities related to managing changes, including conducting risk and design impact assessments.

• Update and maintain product Design History File (DHF) & Drug Master File (DMF) based on change activities.

• Coordinate mentorship with other Design Sub-team members. Develop design, process, and usability FMEAs. Maintain Risk Management File per ISO14971.

• Develop or assist in development and qualification of inspection and test methods and equipment. 

• Develop and document the Control Plan / System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.

• Support the development of manufacturing control plans for internal and outsourced processes.

• Support (or lead) development of the PFMEA, Process Requirements Specifications (PRS), and Validation Plans and Protocols including developing statistical sampling requirements.

• Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.

• Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, CMC, and ISO13485 requirements. 

• Lead supplier part qualification activities including mold qualification and DOEs (PPAP).

• Support Design / Process Transfers to the Production facilities as well as line expansion / capacity / productivity changes.

Other:

• Supports new global expansion efforts for existing products.

• Liaison between OUS quality and plant quality.

• Support the disposition investigation and decisions of rejected nonconforming components and products; conduct MRB action when required.

• Organize and generate detailed quality information reports to show trends and the impact of process improvements.

• Conduct other Quality Control Projects as assigned by the Manager of Quality Engineering.

• Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.

• Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process va