Quality Assurance Specialist

Prescott's Group; Monument (CO); Hybrid; USD 65,000 - 70,000; Full time

Benefits offered by this job

Salary $65k–$70k annually

Health, dental, vision insurance

401K with company matching

Paid time off

Job summary

Prescott's Inc., a leading medical device services company, is seeking a Quality Assurance Specialist to bolster the QMS, ensure ISO 13485 and FDA QSR compliance, and drive continuous improvement in a regulated environment.

You will coordinate nonconformance and CAPA, manage calibration and quality metrics, and collaborate across departments to improve efficiency and customer satisfaction. Onsite in Monument, CO or Kansas City, MO or Costa Mesa, CA with potential for partial remote work.

Qualifications

• 2-3+ years of experience in quality assurance, quality control, or inspection in regulated manufacturing environments.
• Strong knowledge of QMS and inspection documentation practices; ability to read technical specs and schematics.
• Excellent attention to detail and record-keeping; effective written and verbal communication.

Responsibilities

• Maintain and support the QMS in line with ISO 13485 and FDA QSR requirements.
• Create, revise, and maintain QC documentation including SOPs and inspection records.
• Support internal and external audits with adequate documentation and evidence of compliance.
• Assist with supplier quality evaluations and CAPA processes.
• Track quality metrics and CAPA status; drive continuous improvement and defect reduction.
• Collaborate with Operations, Technical Support, and Sales to communicate trends and risks.

Skills

Quality assurance

Documentation

Regulatory knowledge

Cross-functional collaboration

Education

High school diploma or GED

Associate's or Bachelor's degree preferred

Job description

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.

Required Qualifications

• High school diploma or GED required; Associate's or Bachelor's degree in a related field preferred.
• 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)

Preferred Qualifications

• Experience with ISO 13485 or FDA 21 CFR Part 820 quality systems.
• ASQ certification (CQA, CQT, or CQI) or equivalent.
• Experience with medical device refurbishment, biomedical equipment, or healthcare technology.
• Familiarity with CAPA and non-conformance.
• Experience with EQMS (Electronic Quality Management System)

What we offer:

At Prescott's, we prioritize your well-being and growth with a comprehensive benefits package including:

• Salary for this position will be between $65,000 to $70,000 annually
• Paid time off

• Healthcare insurance (medical dental, and vision coverage)
• Accident insurance, critical illness, and hospital indemnity insurance
• Short term (employee paid) and long-term disability (employer paid)
• 401K plan with company matching
• Continuous learning and development - offering opportunities for training, workshops, and certifications
• Our fun and inclusive work environment celebrates diversity and fosters growth, making every day an opportunity to thrive