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. 

LifeCenter Northwest offers medical, dental, vision, basic life insurance, accidental death & dismemberment insurance, long-term disability insurance, and travel accident insurance. Employees have the option of enrolling in the following supplemental or voluntary plans: life insurance, short-term disability, accident insurance, hospital indemnity, critical illness coverage and pet insurance. Employees enrolled in our 403(b) program will receive an employer match of up to 7% after one year, employees are auto enrolled at 3% and may change their enrollment at any time. LifeCenter encourages all employees to find balance and well-being and provides all employees access to an Employee Assistance Program (EAP) and provides a quarterly Wellness Reimbursement. Employees enjoy paid holidays throughout the calendar year and earn 119 hours of PTO annually (to start) as well as Health Time Off hours that is earned 1 hour per 30 worked, paid living donor leave, two weeks paid jury duty leave after 6 months of service, and three weeks of paid parental leave after one year of service is complete. A comprehensive review of benefits can be found at https://lcnw.org/about/employment-opportunities/.

PAY RANGE

$34.03 - $49.35 Hourly

The pay range for this role is provided above. Where a candidate’s compensation falls within this range is based on several bona fide factors such as experience, tenure, and other specialized knowledge. LifeCenter Northwest is committed to providing its employees equitable and competitive compensation.

This position is eligible for compensation in addition to the base pay in the form of overtime.

LifeCenter Northwest is proud to be an Equal Opportunity Employer.