Quality Systems Specialist

Job Details

Location:

Bellevue HQ - Bellevue, WA 98006

Position Type:
Full Time

Salary Range: $34.03 - $49.35 hourly

• Coordinates all document control activities related to Life Center 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 and 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 and 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 Life Center Policies and Procedures are reflective of these requirements.
• Participates in industry meetings and learning opportunities with other OPOs nationally, as requested.

This position has no formal supervisory responsibilities.

• Participates in, and may lead, employee committees and events.
• Complies with applicable laws, regulations, and Life Center policies and procedures.

• 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).

• 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.

• 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.

Life Center Northwest offers medical, dental, vision, basic life insurance, accidental death & dismemberment insurance, long-term disability insurance, and travel accident insurance.…