Production Quality Engineer

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

The Production Quality Engineer is responsible for establishing, maintaining, and improving the quality systems and production quality processes required for compliant medical device manufacturing.

This role is quality-focused first, with primary responsibility for ensuring compliance with ISO 13485 and FDA QMSR requirements, while also supporting hands‑on problem solving within production operations.

The ideal candidate is a practical, execution-oriented Quality Engineer who is comfortable working directly on the production floor, investigating issues, and driving them to resolution. While the role interfaces with manufacturing, engineering, and supply chain, the core expectation is strong ownership of quality engineering responsibilities.

Job Description

Quality Systems & Regulatory Compliance (Primary Responsibility)

• Develop, implement, and maintain quality system processes aligned with:
  • ISO 13485:2016
  • FDA QMSR / 21 CFR Part 820
• Author and maintain quality documentation, including:
  • SOPs
  • Work instructions
  • Forms and records
• Support and maintain compliance of a predominantly electronic (paperless) QMS
• Ensure adherence to good documentation practices (GDP) and 21 CFR Part 11 (as applicable)
• Support annual FDA establishment registration and device listing activities; assist with preparation, maintenance, and coordination of regulatory submissions, including 510(k) support, technical file/design dossier support, and submission documentation coordination with Regulatory Affairs, as applicable
• Support internal audits and external audits (FDA, ISO certification, MDSAP readiness)
• Investigate nonconforming product and process deviations
• Lead and support CAPA activities, including:
  • Root cause analysis (RCA)
  • Corrective and preventive actions
  • Effectiveness verification
• Support complaint investigations and ensure feedback into manufacturing and process control
• Drive timely and complete resolution of quality events

Production Quality & Hands‑On Problem Solving

• Work directly with production and technicians to:
  • Investigate product and process issues
  • Identify sources of variation and failure modes
  • Implement corrective actions
• Ensure production processes meet defined quality requirements
• Support real‑time decision‑making on product disposition and quality concerns
• Identify and elevate risks to product quality or regulatory compliance
• This role requires a “get your hands dirty” mindset, including active engagement in troubleshooting and issue resolution on the production floor.

Process Validation & Control

• Develop, execute, and maintain:
  • IQ/OQ/PQ validation activities
• Support process changes and assess validation impact
• Ensure processes remain in a validated state
• Support development and maintenance of control plans and process monitoring methods
• Support risk management activities aligned with ISO 14971
• Process FMEA (PFMEA)
• Risk assessment for manufacturing and process changes
• Ensure risk‑based decision making in quality and production activities

Supplier Quality (Supporting Role)

• Support incoming inspection processes and acceptance criteria
• Assist in supplier issue investigations and corrective actions
• Collaborate with supply chain and engineering to ensure material quality

Cross‑Functional Collaboration

• Partner with:
  • Manufacturing
  • Engineering
  • Supply Chain
  • Regulatory / Quality teams
• Provide quality input on:
  • Design changes
  • Manufacturing processes
  • Product performance issues
• Support design transfer and production readiness as needed

Supplier Quality & Material Control

• Support supplier selection, qualification, and evaluation
• Oversee incoming inspection and acceptance criteria
• Participate in supplier audits and drive supplier corrective actions as needed
• Ensure material quality supports consistent production outcomes

Training & Workforce Development

• Train and support technicians performing assembly, testing, and inspection
• Develop training materials and ensure competency and training effectiveness
• Promote best practices in documentation, quality, and process adherence

Benefits and Salary

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, and tuition reimbursement.

Voluntary Self‑Identification

For government reporting purposes, we ask candidates to respond to the below self‑identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Black Canyon Consulting’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A \"recently separated veteran\" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.