---
title: 'Production Quality Engineer at Black Canyon Consulting'
canonical: 'https://feeny.ai/job/production-quality-engineer-black-canyon-consulting-bethesda-75tmzynwqe8c'
type: 'job'
last_seen: '2026-10-14'
---

# Production Quality Engineer at Black Canyon Consulting

- **Company:** Black Canyon Consulting
- **Location:** Bethesda, MD
- **Posted:** 2026-10-02
- **Last confirmed live:** 2026-10-14
- **Apply:** https://job-boards.greenhouse.io/blackcanyonconsulting/jobs/8011874003

## Job description

## Overview

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)

Nonconformance, CAPA & Issue Resolution

- 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 escalate 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

Risk Management

- Support risk management activities aligned with ISO 14971
- Participate in:
- 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.

If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

## About Black Canyon Consulting

## Company Overview
- **One-liner**: Black Canyon Consulting (BCC) is a privately held, woman-owned small business that delivers innovative program and IT management support services to federal research and development programs.
- **Entity Type**: Private (Woman-Owned Small Business, SBA-certified WOSB)
- **Headquarters**: Fairfax, Virginia, United States
- **Founded**: 2017 [bccdc.net](https://www.bccdc.net/)
- **Founders**: Manish Salhotra (Managing Director, Co-Founder) and Haley Esser (Principal / CEO) [sba.gov](https://dsbs.sba.gov/search/dsp_profile.cfm?SAM_UEI=WB3LFMA4KM45) | [linkedin.com](https://www.linkedin.com/company/black-canyon-consulting-llc)

## Core Business
- **Primary industry**: Federal IT consulting and program management support for life sciences, bioinformatics, tool development, and environmental sciences.
- **Target customers**: U.S. federal government agencies (e.g., NIH, HHS) and other R&D-focused organizations.
- **Mission/purpose**: “Integrity, Impact, Innovation” – providing agile, adaptive, customer-focused support to advance national missions. [bccdc.net](https://www.bccdc.net/)

## Products & Services
- **Program Management Support**: Strategic and tactical program oversight, administrative management, and consulting for federal R&D initiatives.
- **IT Management Support**: Custom computer programming, systems design, cloud engineering, DevOps, data engineering, AI/ML, and cybersecurity services.
- **Proprietary Technologies**: BCC leverages its own IT system tools, workflows, and a distributed network of consulting resources to deliver turn-key enterprise solutions. [bccdc.net](https://www.bccdc.net/)
- **GSA Schedule Holder**: Contract #47QTCA18D00JA, providing a streamlined procurement vehicle for federal clients. [gsaelibrary.gsa.gov](https://www.gsaelibrary.gsa.gov/ElibMain/home.do/contractorInfo.do?contractNumber=47QTCA18D00JA&contractorName=BLACK+CANYON+CONSULTING+LLC&executeQuery=YES)

## Market Standing
- **Valuation**: Not publicly available (private company).
- **Key Metric**: Annual revenue not disclosed; total funding not applicable (bootstrapped / organic growth).
- **Notable Investors/Partners**: No external investors; key certifications include WOSB, ISO 9001:2015, ISO 20000-1:2018, ISO/IEC 27001:2022, FISMA compliance, and SOC readiness. [bccdc.net](https://www.bccdc.net/)
- **Growth Signals**: LinkedIn reports 42 employees (+75% year-over-year growth), 65 active job postings on Greenhouse, and a +50% increase in job postings monthly/quarterly. [linkedin.com](https://www.linkedin.com/company/black-canyon-consulting-llc) | [greenhouse.io](http://job-boards.greenhouse.io/blackcanyonconsulting)

## Competitive Advantages
- **Certified Woman-Owned Small Business (WOSB)**: Provides set-aside contracting advantages in the federal market.
- **Deep Federal R&D Focus**: Over 125 years of combined experience in supporting NIH and other research programs.
- **Compliance & Security**: Holds multiple ISO certifications and FISMA, NIST, and PCI-DSS compliance, enabling work on sensitive government systems.
- **Agile Delivery**: Proprietary workflows and IT tools allow rapid, high-value execution for complex program needs. [bccdc.net](https://www.bccdc.net/)

## Strategic Focus
- **Current priorities**: Expanding support for NIH bioinformatics, data platforms (e.g., DailyMed, RxNorm, SRA), and AI/LLM initiatives. Actively hiring for roles like AI/ML Specialist, FHIR API SME, and Platform DevEx Engineer. [greenhouse.io](http://job-boards.greenhouse.io/blackcanyonconsulting)
- **Growth direction**: Continuing to secure federal contracts, growing the consulting workforce, and deepening capabilities in cloud, DevOps, and data science.

## Why Work Here
- **Culture**: Emphasizes “Integrity, Impact, Innovation” with a collaborative, mission-driven environment focused on supporting national research priorities. [bccdc.net](https://www.bccdc.net/)
- **Work location**: Most roles are based in Bethesda, Maryland (NIH campus) or Fairfax, Virginia. Remote/hybrid policy not explicitly stated but likely on-site or hybrid given federal client requirements.
- **Notable perks**: Opportunity to work on high-impact federal R&D programs (e.g., NIH’s National Library of Medicine), professional growth in a rapidly expanding company (75% YoY headcount growth), and exposure to cutting-edge technologies (AI, cloud, bioinformatics). [linkedin.com](https://www.linkedin.com/company/black-canyon-consulting-llc)
- **Engineering culture**: Strong focus on software development, DevOps, data engineering, and AI/ML. Teams are organized into divisions like Software Engineering, Platform & DevOps, and Information Engineering. [greenhouse.io](http://job-boards.greenhouse.io/blackcanyonconsulting)

## Sources
1. [bccdc.net](https://www.bccdc.net/)
2. [greenhouse.io](http://job-boards.greenhouse.io/blackcanyonconsulting)
3. [sba.gov](https://dsbs.sba.gov/search/dsp_profile.cfm?SAM_UEI=WB3LFMA4KM45)
4. [linkedin.com](https://www.linkedin.com/company/black-canyon-consulting-llc)
5. [gsaelibrary.gsa.gov](https://www.gsaelibrary.gsa.gov/ElibMain/home.do/contractorInfo.do?contractNumber=47QTCA18D00JA&contractorName=BLACK+CANYON+CONSULTING+LLC&executeQuery=YES)

## Other roles at Black Canyon Consulting

- [Junior Data Scientist](https://feeny.ai/job/junior-data-scientist-black-canyon-consulting-bethesda-qvd3bjg2npje) — Bethesda, MD
- [Mid-Level C++ Developer](https://feeny.ai/job/mid-level-c-developer-black-canyon-consulting-bethesda-a8cvj9qhehx4) — Bethesda, MD
- [Workforce Management Analyst](https://feeny.ai/job/workforce-management-analyst-black-canyon-consulting-raleigh-3t1xg6xp127n) — Raleigh, NC
- [Senior Business Intelligence Analyst](https://feeny.ai/job/senior-business-intelligence-analyst-black-canyon-consulting-bethesda-6pbf2wr8908n) — Bethesda, MD
- [Junior Reengineering Specialist](https://feeny.ai/job/junior-reengineering-specialist-black-canyon-consulting-bethesda-kfkc991q2xne) — Bethesda, MD
- [Mid-Level Reengineering Specialist](https://feeny.ai/job/mid-level-reengineering-specialist-black-canyon-consulting-bethesda-hsr3fdzkq2x4) — Bethesda, MD
- [Senior Reengineering Specialist](https://feeny.ai/job/senior-reengineering-specialist-black-canyon-consulting-bethesda-tvhg6m20hjne) — Bethesda, MD
- [Junior Solutions Analyst](https://feeny.ai/job/junior-solutions-analyst-black-canyon-consulting-bethesda-7amq5vjjtpfe) — Bethesda, MD
- [Mid-Level Solutions Analyst](https://feeny.ai/job/mid-level-solutions-analyst-black-canyon-consulting-bethesda-2cvk3q8ys4ka) — Bethesda, MD
- [Senior Solutions Analyst](https://feeny.ai/job/senior-solutions-analyst-black-canyon-consulting-bethesda-9yvwqj0r70ge) — Bethesda, MD