QA Specialist, Medical Devices & CAPA Leader

Prescotts Inc; Monument (CO); On-site; USD 65,000 - 70,000; Full time

Benefits offered by this job

Paid time off

Healthcare insurance

Disability insurance

401K with match

Training & development

Diversity & inclusion

Job summary

Prescott’s Med is seeking a Quality Assurance Specialist to ensure the quality, safety, and reliability of medical equipment. You will lead QMS activities, oversee nonconformances and CAPA, and drive continuous improvement in a regulated environment.

The role involves coordinating audits, monitoring calibration, and collaborating with Operations, Technical Support, and Sales to communicate quality trends. Based onsite in Monument, CO, with travel as 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)

Responsibilities

• Conduct calibration monitoring on calibrated equipment.
• Maintain and support the QMS in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other regulatory requirements.
• Create, revise, and maintain quality documentation (work instructions, inspection checklists, SOPs, inspection records).
• Assist with internal and external audits by preparing documentation and evidence of compliance.
• Assist with supplier and vendor quality evaluations as needed.
• Initiate and track non-conformance reports (NCRs) and coordinate root cause analysis.
• Support CAPA process and track actions through to closure.
• Escalate recurring or high-risk quality issues to the Quality Manager and leads.
• Track and report quality metrics and suggest process improvements.
• Participate in cross-functional meetings to communicate quality trends and risks.
• Perform other duties as assigned

Skills

Attention to detail

Written and verbal communication

Read technical specifications

Team collaboration

Travel readiness

Education

HS diploma or GED

Associate's or Bachelor's degree preferred

Job description

Prescott’s Med is seeking a Quality Assurance Specialist to ensure the quality, safety, and reliability of medical equipment. You will lead QMS activities, oversee nonconformances and CAPA, and drive continuous improvement in a regulated environment.

The role involves coordinating audits, monitoring calibration, and collaborating with Operations, Technical Support, and Sales to communicate quality trends. Based onsite in Monument, CO, with travel as required.