The Quality Systems Specialist II (QSS II) functions in collaboration with the Manager, Quality Systems in conducting quality-focused programs, applications, and functions for the organization to ensure compliance with LifeCenter policies, applicable regulations, and standards. The QSS assists in the collection, evaluation, and review of quality documentation and participates in quality improvement projects, companywide.
General Responsibilities
- Conducts routine audits of data, information, procedures, equipment, and systems (including computer systems), and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), accreditation standards, and applicable regulations.
- Performs supplier/vendor audits.
- Prepares for and hosts accreditation surveys, regulatory audits, and site visits from donation partners. Consults with staff from other organizations regarding current quality issues and improvement activities.
- Collaborates with management in developing resolutions for audit findings. The QSS II will also be responsible for the assessment of corrective and preventative actions (CAPA’s ) effectiveness and identification of any additional follow-up required for internal and external including supplier audit findings.
- Assists departmental management in developing Standard Operating Procedures compliant with applicable regulations, industry standards, and state law.
- Assists in the timely investigation and closure of non-conformance reports (complaints, deviations, surgical errors, etc.), root cause determination, and development and execution of associated CAPAs.
- Collects, and analyzes data and develops reports on relevant quality performance indicators.
- Participates in process improvement activities throughout the organization.
- Assists in the development, coordination, and presentation of LifeCenter’s training and educational programs company-wide.
- Assists the Manager, Quality Systems with strategic planning and selection of quality processes to implement at LifeCenter Northwest (LCNW).
- Ensures timely review of quality control documentation (e.g. calibration, facility cleaning, sterilization of instruments, and materials management).
- Assists in designated system administration and electronic system validation activities as directed for the Electronic Donor Record System and Electronic Quality Management System.
- Displays effective leadership and coaching skills and drives quality compliance and improvement.
Supervisory Responsibilities
- This position has no formal supervisory responsibilities.
Other Responsibilities
- Performs other related duties as required by the needs of the company and the leadership team.
- Participates in, and may lead, employee committees and events.
- Complies with applicable laws, regulations, and LifeCenter policies and procedures.
- Participates in industry meetings and learning opportunities with other partner organizations nationally.
KNOWLEDGE, SKILLS, ABILITIES
- Demonstrated expertise related to principles and application of quality and quality improvement tools.
- Excellent written and verbal skills, including proven experience with technical writing, specifically SOPs. Must also be comfortable leading training and speaking in front of a group of people.
- Ability to learn and implement procedures in compliance with applicable local/state/federal regulations, certifications, accreditations, etc.
- Multi-tasking, i.e., ability to function and complete work with competing priorities and expectations, and good problem-solving skills.
- Personal and interpersonal skills, i.e., clear speaking, discreet, considerate, sensitive, and collaborative. Must have the ability to function independently as well as in a team setting.
- Strong attention to detail and good follow-through.
- Advanced knowledge of personal computers with superior 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.
ANTICIPATED WEEKLY TIME COMMITMENT
This position may require work outside of regular business hours, including evenings and weekends, sometimes without advance notice.
EDUCATION, EXPERIENCE & JOB REQUIREMENTS
- A bachelor’s degree is preferred though relevant work experience can be considered and substituted for academic requirements.
- Minimum 3 years experience in the documentation, investigation, and resolution of deviations & CAPAs is preferred
- Certified Quality Engineer preferred
- Certified Internal Lead quality auditor preferred
- Documented training courses and/or certifications in Quality Assurance are preferred.
- A minimum of 3 years of experience that is directly related to Quality in a regulated industry is preferred (e.g. CMS, FDA).
- Proof of COVID-19 vaccination, or applicable medical or religious exemption will be required as a condition of employment upon offer. For those that need to complete the vaccination series, start dates will be adjusted.
