On‑Floor Production Quality Engineer (Med Devices)

Black Canyon Consulting; Bethesda (MD); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k plan

Paid holidays

Vacation

Tuition reimbursement

Job summary

Black Canyon Consulting is seeking a Production Quality Engineer to establish, maintain, and improve ISO 13485 and FDA QMSR aligned quality systems for compliant medical device manufacturing.

The role focuses on hands-on problem solving on the production floor, driving CAPA, investigations, and risk management with cross-functional teams to ensure product quality and regulatory readiness.

Qualifications

• Experience establishing and sustaining medical device quality systems.
• Ability to investigate product/process issues on the manufacturing floor.
• Strong knowledge of ISO 13485, FDA QMSR, and 21 CFR Part 11.

Responsibilities

• Develop and maintain quality system processes aligned with ISO 13485 and FDA QMSR.
• Lead CAPA activities including RCA and effectiveness verification.
• Support supplier quality, process validation, PFMEA, and risk assessments.
• Partner with Manufacturing, Engineering, Supply Chain, and Regulatory teams.
• Investigate nonconformances and ensure timely resolution on the production floor.

Skills

ISO 13485 compliance

FDA QMSR knowledge

21 CFR Part 11

GDP / documentation practices

CAPA leadership

RCA & problem solving

Quality in production floor

Risk management (ISO 14971)

PFMEA & process validation

Tools

QMS software

Job description

Black Canyon Consulting is seeking a Production Quality Engineer to establish, maintain, and improve ISO 13485 and FDA QMSR aligned quality systems for compliant medical device manufacturing.

The role focuses on hands-on problem solving on the production floor, driving CAPA, investigations, and risk management with cross-functional teams to ensure product quality and regulatory readiness.