Quality Systems Specialist

About the role

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.

Responsibilities

• Captures 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.
• Aids 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).
• Aids in the timely investigation of non-conformance reports (complaints, deviations, audit findings, etc.) and root cause determination.
• Aids in the corrective and preventative actions (CAPA’s) effectiveness verification activities. Ensures verification is recorded in the EQMS.
• 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.

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.

Qualifications

• 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).

Skills

• Multi-tasking ability.

Benefits

• Medical, dental, vision, basic life insurance, accidental death & dismemberment insurance, long-term disability insurance, and travel accident insurance.
• Supplemental or voluntary plans: life insurance, short-term disability, accident insurance, hospital indemnity, critical illness coverage and pet insurance.
• 403(b) program with an employer match of up to 7% after one year.
• Employee Assistance Program (EAP) and quarterly Wellness Reimbursement.
• Paid holidays, PTO, health time off, paid living donor leave, paid jury duty leave, and paid parental leave.

Pay

The pay range for this role is $34.03 - $49.35 hourly. 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.