Quality Management Coordinator

Quality Management Coordinator

The Quality Management Coordinator will assist in monitoring and applying the laboratorys quality management system (QMS) ensuring compliance with CAP CLIA and applicable regulatory requirements. This position will collaborate with cross-functional teams to identify opportunities for quality improvement develop and implement corrective and preventive actions and maintain a culture of quality continuous improvement and patient-centric excellence. This is an onsite position.

Responsibilities include but are not limited to:

Quality System Oversight:

• Assist in maintaining the laboratorys QMS in compliance with CAP and CLIA requirements
• Monitor completion and documentation of all proficiency testing activities
• Develop review and update policies and procedures related to quality assurance and regulatory compliance with guidance from management
• Monthly meetings with quality manager to review quality management activities

Audits and Inspections:

• Coordinate internal and external audits including CAP inspections CLIA assessments and client qualification audits
• Prepare and submit required documentation to regulatory and accrediting bodies
• Assist in the maintenance and monitoring of CAP-related proficiency activities self-inspections on-site inspections and coordinating responses to CAP
• Address non-conformances by developing corrective action plans and monitoring their effectiveness

Quality Improvement:

• Analyze quality metrics and key performance indicators to identify trends and areas for improvement
• Assist with quality improvement initiatives and ensure implementation of best practices with guidance from management

Training and Communication:

• Prepare and present quality activity updates for staff
• Educate staff on quality and regulatory requirements through training sessions and workshops
• Serve as the primary point of contact for quality-related inquiries
• Alert and coordinate with management when deviations or quality concerns are detected

Document Control:

• Monitor and review document control processes ensuring timely updates and availability of quality documents
• Assist in monitoring company documentation related to instrument and equipment performance
• Assist in documentation of instrument service for review by regulatory agencies
• Assist in maintaining documentation in support of FDA reviewed assays

• Maintain a centralized system for managing policies procedures and records

Incident Management:

• Monitor and investigate quality incidents deviations and complaints
• Conduct root cause analyses and recommend corrective and preventive actions (CAPAs)

Collaboration:

• Work closely with laboratory leadership technical staff and external stakeholders to ensure alignment with quality objectives
• Provide updates and communicate with Quality Management to maintain review and oversight processes

Qualifications:

Minimum of a Bachelors degree Bachelor of Science preferred

Extensive experience in a technical specialty or clinical environment preferred

Experience interpreting and applying regulatory standards from CAP CLIA and FDA

Experience with GxP systems preferred

Experience in successful troubleshooting and quality control

Demonstrates an innovative creative and collaborative approach in the workplace and specifically to quality control

Strong communication skills including accurately understanding others perspectives and an ability to build consensus among different stakeholders

Excellent systemic and independent organizational skills such as identification and reduction of inefficiencies and appropriate prioritization of role responsibilities

Physical presence at our Seattle laboratory is an essential job function of this role hybrid remote scheduling will be considered on a case-by-case basis

HematoLogics is proud to be an Equal Opportunity Employer. We are committed to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application please communicate this need to Human Resources by emailing
.

Full-time physical presence at our Seattle laboratory is an essential job function of this role.

Compensation & Benefits Package:

HematoLogics offers a comprehensive compensation and benefits package which includes medical vision and dental insurance with 100% of monthly premiums paid by the company for employees and 50% of premiums paid for an employees spouse/partner/dependents. Long-term disability coverage is provided with 100% of monthly premiums paid for by the company. We offer up to 6% match at 6 months tenure and beyond for 401K contributions by the employee.

We offer 12 days of vacation (on an accrual basis) 10 days of sick time (front-loaded at the time of your start date) and 11 paid holidays. We offer tuition reimbursement anniversary awards profit-sharing bonuses 100% coverage of ORCA card or $50 per month onsite parking and a variety of other benefits to recognize our teams meaningful contributions to patient care and the company.

Required Experience:

Junior IC