Quality Systems Specialist

The Quality Systems Specialist (QSS I) will assist the Manager, Quality Systems, in the facilitation of the quality management system and process improvement activities for the organization. This position will be an integral part of the continuous improvement efforts of LifeCenter while ensuring compliance with internal policy, industry standards, and applicable regulations. ESSENTIAL JOB FUNCTIONS General Responsibilities Coordinates all document control activities related to LifeCenter Northwest's Quality Management System (QMS) including formatting, distribution, and linking of documents within the electronic document control system. Assists document owners with the creation of documents including procedures, work instructions, and forms, ensuring consistency and quality of content. Coordinates with organizational stakeholders to help ensure effective and efficient rollout of controlled documents. Performs routine audits of procedures, equipment, and other internal processes/areas as directed to ensure compliance with Standard Operating Procedures (SOPs), accreditation standards, and applicable regulations. Prepares audit reports in collaboration with the Quality Systems Manager. Ensures that audit results are formally recorded in the Electronic Quality Management System (EQMS). Assists in the timely investigation of non-conformance reports (complaints, deviations, audit findings, etc.) and root cause determination. Assists in the corrective and preventative actions (CAPA’s) effectiveness verification activities. Ensures verification is recorded in the EQMS. Performs routine review and maintenance of quality documentation e.g. temperature records, sterilization records, licensing, and accreditation documents. Supports and participates in the preparation and hosting of internal, external, and regulatory audits. Performs data collection and information gathering/research for quality and regulatory purposes. Maintains spreadsheets and databases used to document and track quality and regulatory activities (e.g. audits, supplier approvals, assets, documents, non-conformance, etc.) Creates and distributes manager reports regarding quality systems activities. Maintains a current working knowledge regarding applicable regulation and industry standards (e.g., CMS, FDA, etc.) and helps ensure LifeCenter Policies and Procedures are reflective of these requirements. Participates in industry meetings and learning opportunities with other OPOs nationally, as requested. Supervision This position has no formal supervisory responsibilities. Other Responsibilities Participates in, and may lead, employee committees and events. Complies with applicable laws, regulations, and LifeCenter policies and procedures. KNOWLEDGE, SKILLS, ABILITIES Ability to multi-task i.e. complete work managing competing priorities and directives. Strong problem-solving skills and mindset. Excellent written and verbal skills, including the ability to prepare correspondence, manuals, and presentations with minimal supervision. Strong attention to detail and good follow-through. Ability to work successfully both as a team member and independently. Working knowledge of personal computers with skills in desktop programs (e.g., Outlook, Word, Excel, Access, Project, Visio, PowerPoint, and other comparable software programs). BEHAVIORAL REQUIREMENTS The employee in this position must uphold the core values of LifeCenter; these include: Integrity : We are trustworthy, reliable, respectful, and accountable. Collaboration : We work in partnership with others, seeking to understand and be understood, and finding common ground and shared goals to build upon together. Courage : We take personal responsibility and face challenges head-on. Service : Through professionalism and dedication, we honor our commitment to serve others and our obligation to be good stewards of the gift of life . EDUCATION, EXPERIENCE & JOB REQUIREMENTS Bachelor’s Degree from an accredited university/college is required. A minimum of 2 years of quality-related experience is required. Certification or other formal Quality Assurance training is preferred. Relevant work experience can be considered and substituted for academic requirements. Proof of COVID-19 vaccination or applicable medical or religious exemption will be required as a condition of employment upon offer.