Job Description Summary

As directed by the Quality Systems Manager, the Quality Systems Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems as well as maintaining compliance with regulations, standards, and corporate requirements. This position actively participates in quality guidance, product resolution decisions, and statistical problem-solving techniques to supplier quality management, new product development, sustaining product teams, and project and quality network teams for process improvement and continuous improvement activities. This position also supports complaint evaluations, general data analysis for trends, and review of trends with Operations, Quality, Engineering, and the Leadership Team. Additionally, this position may be the Plant Audit Lead and ensures all internal, customer, and third-party audits (regulatory and standards) are successfully completed.

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 responsibilities include but are not limited to:

• Assist in the selection and qualification of suppliers to provide materials that meet specifications for production requirements. 

• Manage operations when nonconformances occur, as needed with accepted quality engineer tools. 

• Analyze, summarize, and report site quality performance to management. 

• Collaborate with manufacturing personnel to review customer complaints and identify improvements required for conformance. 

• Assist with maintenance of the internal audit program. 

• Perform internal audits as a part of an audit team and support external audits as needed. 

• Participates in applicable CAPA activities to accomplish internal/external objectives. 

• Accumulate and prepare quality information reports on a timely basis. 

• Give direction concerning product quality using approved documentation.

• Provide site support for the training program.

• Sustaining activities, this person will understand, improve, and control operational processes to realize predictable product flow while satisfying established BD standards of quality. Successful performance requires close work with quality management, operations, suppliers, and/or BD associates to assure compliance with all BD policies, procedures, and practices. Providing critical quality engineering direction to projects with respect to quality engineering tools/principals.

• Performing tasks, of moderate complexity, within planned schedules and timelines, performing and supporting audits, actively leading or participating on project teams, ensuring documentation compliance, and handling customer complaint investigation/resolution. 

• Intermediate understanding of quality system policies, procedures, and applications to provide guidance on product or project teams. 

• Develop and revise site policies and procedures in accordance with Corporate, Unit, Regional, and Regulatory requirements.  

• Develops solutions to routine assigned activities of broad or narrow scope (e.g., Document change, Complaint file entry, CAPA documentation ...), working within or across functions/business units. 

• Prepares reports and summaries, including quantitative and qualitative analysis.  

• Provide evaluations of all complaints submitted for review by the manufacturing plant or DC and entering the information within the complaint management system.   

• Applies moderate level application of technical principles, theories, concepts, techniques, and quality sciences / tools both in performing failure analyses from complaint product and identifying trends associated with specific defects or products. 

• Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements. 

• Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze customer complaint levels, fail