Quality Assurance Specialist
Prescott's Med
Summary
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.
Job description
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.
Requirements
- High school diploma or GED required
- 2-3+ years of experience in quality assurance, quality control, or inspection, ideally within medical devices, electronics, or a regulated manufacturing environment
- Working knowledge of quality management systems (QMS) and inspection documentation practices
- Ability to read and interpret technical specifications, schematics, and work instructions
- Strong attention to detail and accurate record-keeping skills
- Effective written and verbal communication skills for documenting findings and collaborating across teams
- Must be able to travel 10%-15% (at least once per quarter)
- Associate's or Bachelor's degree in a related field preferred
- Experience with ISO 13485 or FDA 21 CFR Part 820 quality systems preferred
- ASQ certification (CQA, CQT, or CQI) or equivalent preferred
- Experience with medical device refurbishment, biomedical equipment, or healthcare technology preferred
- Familiarity with CAPA and non-conformance preferred
- Experience with EQMS (Electronic Quality Management System) preferred
Benefits
- Paid Time Off
- Medical, Dental & Vision
- Accident Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Short-Term Disability
- Long-Term Disability
- 401(k) Matching
- Training & Certifications
Company overview
Prescott's Med is a leading U.S. provider of healthcare medical equipment repair, maintenance, refurbishment, and rental solutions. Founded in 1984 by Paul and Judy Redner, the company began in surgical microscope distribution and refurbishment before expanding into a comprehensive service platform. Today, Prescott's Med unites several specialized brands—including Heartland Medical, Adepto Medical, Pioneer BioMedical, PM Medical, and Tenacore—offering a single vendor for critical surgical suite equipment such as surgical microscopes, anesthesia machines, infusion pumps, patient monitors, sterilizers, and washers. The company serves health systems, outpatient facilities, and clinics nationwide and in the UK through a differentiated workforce of certified, factory-trained biomedical technicians. Prescott's Med emphasizes rapid 24-hour response times, ISO 13485-certified service, and an industry-leading two-year warranty, helping healthcare providers reduce equipment downtime, simplify equipment management, and lower repair and maintenance costs. In 2024, Morgan Stanley Capital Partners agreed to acquire the company.