Quality Management Specialist
Location: Pittsburgh, PA
Job Type: Contract
Under limited direction of the Director, the QMS Specialist is responsible for coordinating and leading activity related to the organization’s overall Quality Management System (QMS), as well as participating in activities aimed at Quality Improvement initiatives. The QMS Specialist provides valuable insights to influence and drive change with our customer service, operational, support and senior management. This role plays an active role in maintaining and building enterprise quality management processes and controls ensuring company products and service meet or exceed customer requirements and conform to applicable standards and regulations.
- Ensure the QMS conforms to applicable regulations and customer expectations
- Identifies areas for improvement in Quality System SOPs and other controlled documents
- Evaluates existing processes, SOP’s and other controlled documents for consistency and clarity
- Implements document changes as needed.
- Primary coordinator and investigator for the corrective & preventive actions (CAPA) process
- Monitors, analyzes, and tracks the implementation and effectiveness of CAPAs
- Supports the management of Change Control, Document Control, Supplier Qualification and Non-Conformance processes
- Assists with electronic LMS System; ensures training is current.
- Technical lead role for certain projects, in the context of company-wide or department-specific quality initiatives.
- Creates training materials and leads training sessions as needed (e.g. annual HIPAA training)
- Present training sessions on quality and compliance
- Leads or participates internal and external audits
- Maintains a continuous state of audit-readiness in collaboration with Director of QARA
- Applies statistical methods in support of tracking/trending of quality system or operational data, and participates in root cause analysis and problem solving for problems identified
- Write reports and present quality data to cross-functional teams or stakeholders, peers and superiors.
- Perform root cause analysis for problems and propose solutions
- Other duties as assigned
Education & Experience:
- Bachelor’s degree or equivalent in a science, technology, mathematics, engineering, quality or related field, required. Master’s degree preferred.
- 3+years’ experience in quality systems management, quality assurance, quality improvement or related area required.
- Firm understanding of scope and application of regulatory and compliance concepts
- Proven ability in data analysis
- Experience developing training material and platform presentation skills leading training sessions in matters related to quality and compliance
- Ability to analyze and apply federal, state and local laws governing company scope i.e.: software design, healthcare, and medical hub services.
- Excellent written and verbal communication skills