Top 64 Quality engineer medical device Jobs in Herndon, Va

Production Quality Engineer
Blu Omega LLC —Dulles, VA
- $115,000 - $200,000 a year
- 5 years
- Engineering
- US work authorization
- AD&D insurance
- Paid holidays
Micro-electromechanical Systems (MEMS) Engineer
General Technical Services, LLC —Adelphi, MD
- Full-time
- Background check
- Writing skills
- Microsoft Office
- Health savings account
- Relocation assistance
Quick Apply
Electrical Designer / Engineer
ATI, Inc. —Bethesda, MD
- $115,000 - $130,000 a year
- Full-time
- Microsoft Word
- Background check
- AutoCAD
- Paid holidays
- Disability insurance
Quick Apply
Production Quality Engineer
Blu Omega —Dulles, VA
- $115,000 - $200,000 a year
- 5 years
- Engineering
- US work authorization
- AD&D insurance
- Paid holidays
Biomedical Engineer / LMDI SME
Blue Water Thinking —Washington, DC
- $90,000 - $120,000 a year
- Oracle
- Mid-level
- 3 years
- Paid holidays
- Health insurance
Quick Apply
Quality Assurance / Configuration Management Lead - Topsecret
Parsons —Centreville, VA
- $103,500 - $181,100 a year
- Computer Science
- Engineering
- Office
- Wellness program
- Paid holidays
Quality Engineer
Mpr Associates, Inc. —Alexandria, VA
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
CQV Engineer I
IPS-Integrated Project Services —Germantown, MD
- $67,000 - $102,000 a year
- Full-time
- Construction site
- Ability to walk for extended periods
- Bachelor of Science
FAB Engineer
Micron —Manassas, VA
- Mid-level
- 3 years
- Mentoring
- Employee stock purchase plan
- Paid holidays
Controls Design Engineer (EPMS), CDE
Amazon Data Services, Inc. —Herndon, VA
- $116,800 - $160,000 a year
- Full-time
- Bachelor of Science
- Data analysis skills
- System design
- AD&D insurance
- Health insurance
Biomedical Engineer
RWD Consulting —Bethesda, MD
- Computer literacy
- Bachelor of Science
- English
Quick Apply
Junior Biocontainment Engineer (Mechanical Engineer) 04160 LBYD Federal
North Wind Group —Bethesda, MD
- $80,000 - $85,000 a year
- Part-time
- Construction site
- Engineering
- Travel
- Wellness program
- Disability insurance
Controls Design Engineer, Controls Design Engineering
Amazon Data Services, Inc. —Herndon, VA
- $116,800 - $160,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Research
- AD&D insurance
- Health insurance
Sr DRAM Product Engineer
Micron —Manassas, VA
- Mid-level
- Master's degree
- In-person
- Employee stock purchase plan
- Paid holidays
Engineer II, Microfluidic
Meso Scale Diagnostics, LLC. —Gaithersburg, MD
- $88,100 - $134,400 a year
- Analysis skills
- Ability to sit for extended periods
- Software development
- Paid parental leave
- AD&D insurance
Quick Apply
Mission Crew Trainer Technical Architect (Onsite)
Collins Aerospace —Sterling, VA
- $145,600 - $276,800 a year
- Full-time
- 7 years
- Business development
- Mentoring
- Paid holidays
- Loan repayment program
Integration & Test Engineer, Space Electronics
TRIDENT SYSTEMS LLC —Sterling, VA
- $61,000 - $113,000 a year
- Full-time
- Continuous improvement
- Senior level
- Electrical Engineering
- Health savings account
- AD&D insurance
Quick Apply
Subregional Design Lead
Digital Realty —Ashburn, VA
- $200,000 - $225,000 a year
- Full-time
- Hybrid work
- 7 years
- Construction site
- Master's degree
- AD&D insurance
- Employee stock purchase plan
13d
Senior Validation Engineer
Katalyst Healthcares & Life Sciences —Silver Spring, MD
- Contract
- 5 years
- Senior level
- Commercial
Quick Apply
Mechanical Engineer - Multiple Levels (Engineer Mechanical)
HII —Alexandria, VA
- $96,325 - $192,801 a year
- Email
- Mid-level
- Master's degree
- Analysis skills
- Paid holidays
- Health insurance

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quality engineer medical device jobs near herndon, va

Production Quality Engineer

Blu Omega LLC
Dulles, VA

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Job Details

$115,000 - $200,000 a year

Benefits

AD&D insurance
Paid holidays
Disability insurance
Health insurance
Dental insurance
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Pet insurance

Qualifications

FDA submissions
Defect resolution root cause analysis
Production deviation management
Corrective and preventive actions (CAPA)
FDA 21 CFR Part 11
Quality control audit
Production validation processes
Medical device manufacturing facility experience
Compliance documentation
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Regulatory submissions
Quality audits
ISO 13485
Audit support
Failure analysis

Full Job Description

Production Quality Engineer

Blu Omega is seeking a Production Quality Engineer to support compliant medical device manufacturing. This role operates within a medical device production environment and is responsible for establishing, maintaining, and improving quality systems and production quality processes to support regulatory compliance.

Program Overview

Program: Medical device manufacturing quality and compliance
Mission overview: Ensure compliant production quality systems and processes for medical device manufacturing.

Key Details

Location: Dulles, VA
Clearance: No clearance required
Work Authorization: Applicants must be legally authorized to work in the United States without current or future sponsorship.

Responsibilities

Quality Systems & Regulatory Compliance (Primary Responsibility): Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and FDA QMSR / 21 CFR Part 820
Quality Documentation: Author and maintain quality documentation, including SOPs, work instructions, and forms and records
Paperless QMS Compliance: Support and maintain compliance of a predominantly electronic (paperless) QMS
Documentation Practices: Ensure adherence to good documentation practices (GDP) and 21 CFR Part 11 (as applicable)
Regulatory Support: 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
Audit Support: 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, and effectiveness verification
Complaints: Support complaint investigations and ensure feedback into manufacturing and process control
Quality Event Resolution: 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, and ensure production processes meet defined quality requirements
Disposition & Risk Escalation: Support real-time decision-making on product disposition and quality concerns; identify and escalate risks to product quality or regulatory compliance
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, including participation in Process FMEA (PFMEA) and 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
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

Required Qualifications

Bachelor’s degree in Engineering or related technical field
5–8 years of experience in medical device quality engineering (ISO 13485 / FDA regulated environment) or other medical products quality engineering field
Strong working knowledge of: CAPA and nonconformance systems, root cause analysis methodologies, and quality system documentation
Experience supporting or leading: Process validation (IQ/OQ/PQ), audits (internal or external), and FDA annual establishment registration and device listing, including 510(k) support, technical file/design dossier support, and submission document coordination with Regulatory Affairs
Strong problem-solving skills with a hands-on approach to issue resolution

Preferred Qualifications

Experience with manufacturing processes (machining, assembly, prototyping, etc.)
Familiarity with mechanical design or CAD tools (e.g., SolidWorks)
Exposure to electronics testing (multimeters, oscilloscopes)
Experience with test systems, automation, or programming (Python, C/C++)
Familiarity with optical systems or measurement technologies
Experience in startup or early-stage manufacturing environments

Compensation

Salary Range: $115,000 - $200,000
Final compensation is based on technical skills, experience, education, certifications, and clearance.

Blu Omega Benefits & Perks

Medical, Dental, and Vision coverage through national providers
401(k) with company match (eligible after 6 months; vesting applies)
Company-paid Life and AD&D insurance with additional voluntary options
Short-term disability (company-paid) and long-term disability options
Employee Assistance Program (EAP) with 24/7 confidential support and mental health resources
Telehealth and virtual care options available through medical plans
Pet insurance, legal services, and identity theft protection options
Paid Time Off (PTO) for eligible employees
Paid federal holidays for salaried employees
Access to wellness programs, discounts, and lifestyle benefits
Benefits eligibility and offerings may vary based on role, employment status, and program requirements.

Company Overview

Blu Omega is a Woman-Owned Small Business (WOSB) delivering technology and cybersecurity solutions to federal agencies and enterprise clients nationwide. Headquartered in Ashburn, VA, we support mission-critical programs across civilian and defense sectors, including health, national security, and regulatory environments. We partner with government agencies and large integrators to provide expertise in cybersecurity operations, cloud and infrastructure modernization, data and analytics, and enterprise IT support. Our teams are experienced operating within federal contracting environments, supporting task orders, recompetes, and programs requiring cleared personnel and compliant delivery.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.

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Refine Your Search

quality engineer medical device jobs in herndon, va

Production Quality Engineer

Micro-electromechanical Systems (MEMS) Engineer

Electrical Designer / Engineer

Production Quality Engineer

Biomedical Engineer / LMDI SME

Quality Assurance / Configuration Management Lead - Topsecret

Quality Engineer

CQV Engineer I

FAB Engineer

Controls Design Engineer (EPMS), CDE

Biomedical Engineer

Junior Biocontainment Engineer (Mechanical Engineer) 04160 LBYD Federal

Controls Design Engineer, Controls Design Engineering

Sr DRAM Product Engineer

Engineer II, Microfluidic

Mission Crew Trainer Technical Architect (Onsite)

Integration & Test Engineer, Space Electronics

Subregional Design Lead

Senior Validation Engineer

Mechanical Engineer - Multiple Levels (Engineer Mechanical)

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