Quality Assurance Specialist

Join the team at Prescott's, Inc. - where quality meets care.

Prescott's is a leading medical device services company, trusted by healthcare professionals across the country. We specialize in the distribution and expert refurbishment of essential medical equipment, including sterilizers, surgical microscopes, pumps, monitors, anesthesia machines, and more. Our mission is to enhance the quality of healthcare by ensuring providers have access to reliable, high-performing equipment. If you"re passionate about supporting the frontlines of care through innovation and service, we'd love to have you on our team.

This position will be supporting Prescott"s Inc and located onsite at our Monument, CO or Kansas City, MO, or Costa Mesa, CA locations. May have the potential to work 1-2 days per week remote.

Join our team as a Quality Assurance Specialist and play a critical role in ensuring the quality, safety, and reliability of medical equipment that makes a difference in patient care. In this role, you"ll help maintain and strengthen our Quality Management System by ensuring products, processes, and documentation comply with ISO 13485, FDA Quality Management System Regulation (QMSR), and other regulatory requirements. Working collaboratively across departments, you"ll lead quality initiatives, manage nonconformance and corrective action processes, monitor calibration and quality metrics, and identify opportunities to improve efficiency, reduce defects, and enhance customer satisfaction. If you"re passionate about quality, continuous improvement, and making a meaningful impact in a regulated environment, we"d love to have you on our team.

Responsibilities:

Inspection & Testing

• Conduct calibration monitoring on calibrated equipment.

Quality Systems & Compliance

• Maintain and support the company"s quality management system (QMS) in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements.
• Create, revise, and maintain quality documentation, including work instructions, inspection checklists, SOPs, and inspection records.
• Support internal and external audits by preparing documentation and evidence of compliance.
• Assist with supplier and vendor quality evaluations as needed.

Non-Conformance & Corrective Action

• Initiate and track non-conformance reports (NCRs) and coordinate root cause analysis with relevant departments.
• Support the corrective and preventive action (CAPA) process, tracking action items through to closure.
• Escalate recurring or high-risk quality issues to the Quality Manager and relevant department leads.

Reporting & Continuous Improvement

• Track and report quality metrics, including defect rates, inspection results, and CAPA status, to management.
• Recommend process improvements to reduce defects, rework, and returns.
• Participate in cross-functional meetings with Operations, Technical Support, and Sales to communicate quality trends and risks.
• Perform other duties as assigned based on business needs.