The Quality Management Systems Coordinator (QMSC) will assist the Director, Quality & Regulatory Affairs (QRA) in facilitation of quality management system and process improvement activities for the organization. This position will be an integral part of continuous improvement efforts of LifeCenter while ensuring compliance with internal policy, industry standards and applicable regulation.

ESSENTIAL JOB FUNCTIONS

Document Control

• Coordinates all document control activities related to the LifeCenter Northwest’s Quality Management System (QMS). Ensures effective control, distribution, traceability, retention and retrievability of documents and quality assurance records.
• Assists document owners with creation of documents including procedures, work instructions, forms, ensuring consistency and quality of content.
• Coordinates with organizational stakeholders to help ensure effective and efficient rollout of change initiatives.

Quality Assurance

• Assists in coordination of all activities related to the QMS, including but not limited to          co-administration of Electronic Quality Management System (EQMS), performing routine review of quality control documentation, and development and execution of validation documentation.
• Supports and/or performs internal and external audit activities. Assists in preparation and hosting of regulatory audits.
• Contributes to development of QMS Key Performance Indicators (KPIs) for development and production of reports to management for the QMS. Assists in identification of improvement opportunities or areas of risk.
• Assists management with timely and appropriate closure of non-conformance reports in accordance with internal policy. This may include employing appropriate quality tools such as Root Cause Analysis, fishbone, scatter diagram, etc.
• Supports the planning, coordination, and presentation of training and educational programs related to the QMS.
• Maintains a current working knowledge in regard to applicable regulation and industry standards (e.g., AOPO, UNOS, CMS, 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. 

KNOWLEDGE, SKILLS, ABILITIES

• Minimum of 1 year of Quality-related experience is required.
• Regulatory and/or 21 CFR Part 11 experience is preferred.
• Ability to create and implement procedures in compliance with applicable local/state/federal regulations, accreditations, certifications, etc.
• Strong problem-solving skills.
• Multi-tasking, i.e., ability to function and complete work with competing priorities and expectations while meeting deadlines.
• Personal and interpersonal skills, i.e., clear speaking, discreet, considerate, sensitive, and collaborative. 
• 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.
• Advanced knowledge of personal computers with superior skills in desktop programs (e.g., Outlook, Word, Excel, Access, Project, Visio, Power Point, and other comparable software programs).

EDUCATION, EXPERIENCE & JOB REQUIREMENTS

- Bachelor’s Degree from an accredited university/college is required.

- Certification or other formal Quality Assurance training is preferred.

- Relevant work experience can be considered and substituted for academic requirements.

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.

LifeCenter Northwest is proud to be an Equal Opportunity Employer.