QA Specialist - Medical Devices & Compliance

Prescott's Med; Monument (CO); On-site; USD 65,000 - 70,000; Full time

Benefits offered by this job

Healthcare insurance (medical, dental,

401K with company match

Paid time off

Job summary

Prescott’s Med is seeking a Quality Assurance Specialist to support regulatory compliance and continuous improvement for medical equipment refurbishment.

You will manage nonconformances, CAPAs, and quality documentation while collaborating with Operations, Technical Support, and Sales to improve defect trends and customer satisfaction. This on-site role in Monument, CO requires 2–3+ years in regulated QA environments.

Qualifications

• 2–3+ years in quality assurance, quality control, or inspection, ideally within medical devices, electronics, or a regulated manufacturing environment.
• High school diploma or GED required; Associate's or Bachelor's degree preferred.
• Working knowledge of quality management systems (QMS) and inspection documentation practices.
• Ability to read and interpret technical specifications, schematics, and work instructions.
• Must be able to travel 10%-15% (at least once per quarter)

Responsibilities

• Inspect, test, and calibrate equipment to ensure accuracy and reliability.
• Maintain and support the QMS in line with ISO 13485, FDA QSR (21 CFR Part 820), and applicable regs.
• Create, revise, and maintain quality documentation including SOPs and inspection records.
• Support internal and external audits with documentation and evidence of compliance.
• Manage nonconformance reports (NCRs) and coordinate root-cause analyses; track CAPA items.
• Monitor quality metrics and drive continuous improvement across departments.

Skills

Quality Assurance

Attention to detail

Communication skills

Reading technical specs

Willingness to travel

Education

Associate's or Bachelor's degree in a related field

Tools

EQMS

Job description

Prescott’s Med is seeking a Quality Assurance Specialist to support regulatory compliance and continuous improvement for medical equipment refurbishment.

You will manage nonconformances, CAPAs, and quality documentation while collaborating with Operations, Technical Support, and Sales to improve defect trends and customer satisfaction. This on-site role in Monument, CO requires 2–3+ years in regulated QA environments.