Job Description Summary

Staff Quality Systems Specialist I – Lead Auditor is responsible for providing Quality and/or technical leadership/supervision to product/projects/systems and direct report teams. Directly accountable for multiple projects within department or has accountability for programs across multiple plants.

Conceptualizes, prioritizes and schedules project deliverables. Determines feasibility of project features, deliverables and resource availability to recommend viable options. Leads continuous improvement activities for the DS Quality System.

The Staff Quality Systems Specialist I – Lead Auditor is directly responsible to the WW Quality Systems Director for the DS-wide development, improvement and implementation of Quality Systems programs. The Staff Quality Systems Specialist I – Lead Auditor is accountable for assuring that all DS sites comply with ISO and FDA (or primary regulations of their respective countries) through the implementation of effective internal quality system audit program and ensuing effective corrective actions/ preventive actions.

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. 

DUTIES, RESPONSIBILITIES & AUTHORITIES:

The Staff Quality Systems Specialist I – Lead Auditor is the QS Subject Matter Expert in one or more areas.

• Collects, interprets and analyzes data and presents to others either orally or in writing.  Understands and leverages published Quality System and regulatory agency requirements and leverages best practices.  Makes recommendations for project direction including alternative solutions. 

• Independently designs quality plans consistent with project objectives.  Readily applies Quality System principles to the solution of complex technical problems.

• Acts independently, consults with supervisor on unusual situations.

• May train, develop or assign work to others; provides technical and or supervisory guidance to others.  May be responsible for on contribute to the assessment and development of associates who are dotted line reports.  May have direct reports.

• Responsible to maintain budget as assigned and assure balance of resource allocation, dollars and equipment.

• Is the prime technical contact on projects and interacts with senior external personnel.

Specifically:

• Develops, documents, administers, and maintains Quality Systems for conformance to regulatory requirements and company policies.

• Develops, documents and executes Baltimore wide Quality Audit Program.

• Coordinates with other DS sites to assure that each site has fully compliant Quality System Audit Program.

• Develops and implements DS wide audit report “Peer Review” program so that audit reporting across the business is uniform, current and effective.

• Supports DS wide Quality System Audit Program by providing independent auditing service when there is a need for support in any particular site.

• Initiates a DS wide Audit Data Trending Programs for management input.

• Supports DS wide continual improvement effort by continually raising the compliance bar during Quality System Audits.

• Assures appropriate corrective action program is implemented for nonconformance issued during internal audits.

• Represents BDDS on cross-business teams related to Quality System Audits.

• Functions on corporate initiated teams regarding implementation and best practice strategies for highly visible Quality System Audit programs.

• Identifies best practices between BD divisions and Corporate to develop one common system.

• Develops and provides compliance/ audit training, including training for auditors and auditees.

• Partners with other quality professionals to address recurring issues identified throughout the organization.

• Provides and analyzes organizational quality audit metrics as required to generate quality system improvements.