Senior Quality Systems Specialist

Description

Summary

The Senior Quality Systems Specialist, Quality Systems performs a variety of complex quality specific duties and supports the Quality Systems Department. This role is responsible for monitoring, coordinating and performing quality assurance activities, quality control and auditing, supports and executes performance improvement activities to ensure regulatory and accrediting agency compliance as they pertain to internal policies, procedures, and practices, organizational goals and industry Standards, Regulations, and Guidance. Such activities may include, but are not limited to, conducting internal and external organizational audits at planned intervals.  Act as a lead quality document management administrator for the Quality Management System (QMS) software; to support audit processes by ensuring appropriate organizational operations.

Essential Duties & Responsibilities

1. Under the direction of the Manager, Quality Systems the Quality Systems Specialist will perform an internal organizational risk analysis to identify quality assurance activities including quality control monitoring and internal auditing with the responsibility to implement annual audit schedule  of the quality audit process within We Are Sharing Hope SC to ensure that the organizational systems are complaint with policies procedures, and practices guided by industry Standards, Regulations, and Guidance.
2. Leads internal audit process of operational department’s quality control checks including the department’s audit practices.
3. Performs external audits in conjunction with the Manager, Quality Systems. Audits are non-exclusive of critical supplier initial qualification audit, routine critical supplier audits, and focused supplier audits resulting from Supplier Corrective Action Report (SCAR) for high-risk occurrence or deviation, and/or those systemic in nature. Communicates with supplier in instances where a SCAR is required
4. Applies the principles, processes, and methods of auditing. Practices personal behaviors necessary for an effective and efficient conduct of audit posture.
5. Maintains supplier program with oversight and support of the Manager, Quality Systems. Develops supplier qualifications for critical and non-critical suppliers (e.g. digital forms), obtains and routinely reviews contractual agreements, ensures all appropriate certifications, licensures, and registrations are current. Ensure the supplier list including contacts are up to date.
6. Administer quality surveillance and application of the QMS software to ensure control of policies and procedures to streamline and automate communication and collaboration of revisions with appropriate approvals. Collaborate with the Manager, Quality Systems and operational leadership to ensure the document lifecycle and content is compliant We Are Sharing Hope SC practices and Standards, Regulations, and Guidance.
7. Alongside the Manager, Quality Systems completes the final quality review within the QSM centralized repository for documents, attachments (e.g. forms) prior to activation.  
8. Supports and executes performance and process improvement activities using a variety of continuous improvement where key performance indicators (KPIs) are analyzed for advantages and disadvantages, including calculating the Cost of Quality (CoQ) and the Cost of Poor Quality (CoPQ) for their operational changes. 
9. Other duties as assigned.

Qualifications

Qualifications, Education & Experience

• BS degree;
• Knowledge of industry specific AATB, FDA, CMS, UNOS/OPTN Regulations
• Prior experience of proven quality success
• Quality certification(s) preferred such as American Society for Quality (ASQ) or the equivalent
• Demonstrates analytical and critical thinking skills, with the creative ability to apply (healthcare) knowledge and expertise
• Self-directed and motivated
• An equivalent combination of education and experience.