Job Description

Job Description Summary

The Staff Quality Systems Specialist II 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 IDS Quality System.

Job Description

The Staff Quality Systems Specialist II 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 or 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. Leads the implementation of Quality System program initiatives for IDS by gathering voice of the customer, defining user requirements, developing/sourcing (in conjunction with Information Technology) electronic systems, implementing procedures and training.

Project management principles will be employed to deliver programs at both the local IDS level and as a member of a BDX team.
Responsible for the creation of quality system programs for IDS in topics that need increased awareness and visibility. Needs assessments, management input, corporate initiatives and FDA focus will be factors in planning the strategy/priorities for such programs. Project may be part of continuous improvement (i.e. preventive action, best practices) or as part of a corrective action.

Develops, documents, administers, and maintains Quality Systems for conformance to regulatory requirements and company policies.
Represents IDS on cross-business teams related to Quality Systems.
Functions on corporate initiated teams regarding implementation and best practice strategies for highly visible Quality System programs.
Identifies and corrects division wide quality system weaknesses.
Partners with other quality professionals to address recurring issues identified throughout the organization.
Interfaces with IDS Leadership Team on Quality System initiatives.
Provides and analyzes organizational quality metrics as required to assess the effectiveness of quality system improvements.
Functions as a resource for the IDS organization for Quality System issues.
May monitor budgets for capital expenditures, operating supplies, and labor.

KNOWLEDGE AND SKILLS:

* Demonstrated ability to lead, motivate and accomplish results through experienced direct reports and peers.
* Ability to organize and prioritize assignments providing direction to assigned functional teams.
* Demonstrates effective written and verbal communication skills across all levels.
* Ability to speak with clarity and manage conflict resolution in a variety of settings; one-on-one interactions, group meetings, and formal presentations.
* Ability and skill to effectively manage multiple tasks and lead execution of change management plans.
* Ability and skill to lead or manage the Quality System function for complex systems, continuous improvement projects and project management techniques.
* Knowledge and understanding of Risk Management and Corrective/Preventative Actions processes.
* Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International organization for Standardization (ISO).
Able to manage budgets and develop capital expenditure requests.

EDUCATION AND EXPERIENCE:

* BA/BS Degree in relevant discipline. Professional certification is an advantage (i.e, Project Management, Training Development, CQE, CMQ/OE, Etc).
* A minimum of 5 years experience in Quality Management/Quality Systems with a focus on Risk Management and Corrective and Preventative Actions, and/or Project Management or 10 years professional experience in the Medical Device Industry.
* Three years of supervisory or management experience recommended.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift