Medical Device QA Engineer: Regulatory & Quality Excellence

Critical Fit Recruiting; Bowling Green (KY); On-site; USD 80,000 - 110,000; Full time

Job summary

Critical Fit Recruiting is seeking a Quality Assurance Engineer to support quality, safety, and regulatory compliance of medical device and medical‑use product lines. You will ensure compliance with FDA, ISO 9001:2015, ISO 13485, and customer requirements, while promoting continuous improvement across cross‑functional teams.

Responsibilities include maintaining QMS, writing SOPs, supporting audits, managing DMR/DHR, leading recalls, conducting risk management with FMEA, and performing

Qualifications

• Bachelor’s degree or 10 years of relevant experience in medical device quality engineering.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 9001.
• Hands-on experience with TMV, CAPA, and nonconformance management.
• Ability to lead cross-functional teams and communicate effectively.

Responsibilities

• Maintain and improve the QMS for medical products in alignment with ISO 9001:2015, ISO 13485, and FDA QSR.
• Create, revise, and review SOPs, Work Instructions, and Form Control Documents supporting medical product quality processes.
• Participate in and support internal audits to ensure readiness for external audits and regulatory inspections.
• Maintain compliant Device Master Records (DMR) and Device History Records (DHR) for all medical products.
• Serve as Recall Coordinator, leading mock and official recall activities for medical product lines.
• Lead and support risk management activities using FMEA and other risk‑reduction tools.
• Participate in root cause analysis, Kaizen events, and structured problem‑solving initiatives focused on medical product quality.

Skills

Analysis Skills

CAPA

Problem Solving

FDA QA/QSR knowledge

ISO 13485 knowledge

FMEA

Root Cause Analysis

Gage R&R

Statistical software (Minitab)

MS Office (Excel, PowerPoint, Word)

Education

Bachelor’s degree in Engineering, Applied Mathematics (with statistics), or a related technical field

10 years of relevant experience in lieu of degree

Tools

Minitab

Microsoft Excel

Microsoft Access

Microsoft PowerPoint

Microsoft Word

Job description

Critical Fit Recruiting is seeking a Quality Assurance Engineer to support quality, safety, and regulatory compliance of medical device and medical‑use product lines. You will ensure compliance with FDA, ISO 9001:2015, ISO 13485, and customer requirements, while promoting continuous improvement across cross‑functional teams.

Responsibilities include maintaining QMS, writing SOPs, supporting audits, managing DMR/DHR, leading recalls, conducting risk management with FMEA, and performing