Production Quality Engineer – On-Floor Problem Solver

Black Canyon Consulting; Ashburn (VA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k with employer contribution

Paid holidays

Vacation

Tuition reimbursement

Job summary

Black Canyon Consulting seeks a Production Quality Engineer to establish and maintain quality systems and production quality processes for compliant medical device manufacturing. The role focuses on ISO 13485 and FDA QMSR compliance while solving issues on the production floor with hands-on ownership.

The ideal candidate drives CAPA, investigations, risk management, and quality documentation, interfacing with Manufacturing, Engineering, Supply Chain, and Regulatory teams to ensure timely issue

Qualifications

• Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and FDA QMSR.
• Author and maintain quality documentation (SOPs, work instructions, forms/records).
• Support GDP and 21 CFR Part 11 compliance and electronic QMS.
• Lead CAPA activities with RCA and effectiveness verification.
• Support audits (FDA, ISO, MDSAP) and regulatory submissions.

Responsibilities

• Investigate nonconforming product and process deviations.
• Lead and support CAPA activities including RCA and effectiveness checks.
• Support complaint investigations and feedback into manufacturing and process control.
• Ensure production processes meet defined quality requirements and real-time product disposition decisions.

Skills

Quality Systems

Regulatory Compliance

CAPA

Root Cause Analysis

Job description

Black Canyon Consulting seeks a Production Quality Engineer to establish and maintain quality systems and production quality processes for compliant medical device manufacturing. The role focuses on ISO 13485 and FDA QMSR compliance while solving issues on the production floor with hands-on ownership.

The ideal candidate drives CAPA, investigations, risk management, and quality documentation, interfacing with Manufacturing, Engineering, Supply Chain, and Regulatory teams to ensure timely issue