Quality Assurance Engineer-Medical

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

We're looking for a Quality Assurance Engineer to support the quality, safety, and regulatory compliance of medical device and medical‑use product lines, ensuring they meet all applicable FDA, ISO, and customer requirements. The position strengthens a culture of continuous improvement, cross‑functional collaboration, and disciplined quality practices.

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.
• Ensure full compliance with cGMP, labeling requirements, and all applicable medical device regulations.
• 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.
• Promote a culture of continuous improvement, operational excellence, and regulatory discipline.
• Prepare and analyze SPC charts for medical products and process parameters.
• Generate and submit PPAP, IQ/OQ/PQ, and other validation or customer-required documentation for new or modified medical products.
• Review and validate management of change documentation prior to commercialization of new or updated medical products.
• Maintain and execute Test Method Validation (TMV) to ensure repeatability and reproducibility of medical product test methods.
• Conduct Gage R&R and inter-laboratory comparison studies and provide data-driven insights.
• Spend approximately 40% of work time performing routine inspection and verification activities on the manufacturing floor.
• Maintain customer feedback and complaint records in accordance with ISO 13485, ISO 9001, and FDA requirements.
• Lead weekly medical product complaint review meetings, ensuring timely follow-up and closure of actions.
• Provide analysis and documentation related to Return Material Authorizations (RMA) for medical products.
• Collaborate with leadership to develop and maintain training curricula specific to medical product quality requirements.
• Partner with cross-functional supervisors to administer competency evaluations and training renewals.
• Ensure training compliance for new or revised SOPs related to medical product quality.
• Support adherence to company policies, principles, and guidelines.
• Rigorously follow and enforce all safety rules and regulations.
• Perform additional duties as needed to support medical product quality and regulatory compliance.

QUALIFICATIONS

• Bachelor’s degree in Engineering, Applied Mathematics (with statistics), or a related technical field; or 10 years of relevant experience in lieu of degree.
• 2–5 years of quality engineering experience in the medical device or medical products industry.
• Proficiency with Minitab, Excel, Access, PowerPoint, and Word.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 9001.
• Hands‑on experience with TMV, CAPA, and nonconformance management.
• Strong analytical, communication, and leadership skills with the ability to influence cross‑functional teams.

Skills

• Analysis Skills
• Change Management
• Communication Skills
• Continuous Improvement
• Corrective and Preventative Action (CAPA) Systems
• Cross-Functional
• Current Good Manufacturing Practice (cGMP)
• Customer/Client Research
• Develop and Maintain Customers
• Document Management
• Documentation
• Engineering
• External Audit
• FDA (Food and Drug Administration)
• FDA Requirements
• Failure Mode and Effects Analysis (FMEA)
• Healthcare Quality
• ISO (International Organization for Standardization)
• ISO 9001
• Internal Audit
• Leadership
• Maintain Compliance
• Manufacturing
• Mathematics
• Medical Equipment
• Medical Products
• Medical Tests
• Microsoft Access Database
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Word
• Minitab
• Operational Improvement
• Organizational Skills
• Problem Solving Skills
• Process Validation
• Product Programs
• Product Reviews
• Product Support
• Product Testing
• Production Part Approval Process (PPAP)
• Quality Assurance
• Quality Assurance Methodology
• Quality Engineering
• Quality System Requirements (QSR)
• Regulations
• Regulatory Compliance
• Return Merchandise Authorization (RMA)
• Risk
• Risk Management
• Root Cause Analysis
• Safety Compliance
• Standard Operating Procedures (SOP)Statistics
• Time Management
• Training/Teaching Curriculum
• Validation Testing