Ensure compliance with regulatory requirements, including FDA regulations and LDT oversight ... Bachelor's degree in Quality Engineering, Quality Management, Business, or related field required;
Ensure compliance with regulatory requirements, including FDA regulations and LDT oversight ... Bachelor's degree in Quality Engineering, Quality Management, Business, or related field required;
QA Test Engineer with Security Clearance
Ashburn, VA · On-site
$110K - $135K/yr
QA Test Engineer Remote Current FDA badge required Blu Omega is seeking a QA Test Engineer to support an FDA program focused on regulated product submissions. This role operates within a remote ...
QA Test Engineer with Security Clearance
Ashburn, VA · On-site
$110K - $135K/yr
QA Test Engineer Remote Current FDA badge required Blu Omega is seeking a QA Test Engineer to support an FDA program focused on regulated product submissions. This role operates within a remote ...
FDA Artificial Intelligence and Machine Learning Fellowship
Silver Spring, MD · On-site
$60 - $80/hr
... high-quality medical devices and safe radiation-emitting products. CDRH provides consumers ... Proficiency in at least one programming language (Python, R, Matlab, etc) * Intelligence * Interest ...
FDA Artificial Intelligence and Machine Learning Fellowship
Silver Spring, MD · On-site
$60 - $80/hr
... high-quality medical devices and safe radiation-emitting products. CDRH provides consumers ... Proficiency in at least one programming language (Python, R, Matlab, etc) * Intelligence * Interest ...
Ensure facility systems are compliant with GMP, FDA, and other applicable regulatory standards. * Collaborate with Manufacturing, QA, EHS, and Engineering to support operational readiness and ongoing ...
Quick apply
Ensure facility systems are compliant with GMP, FDA, and other applicable regulatory standards. * Collaborate with Manufacturing, QA, EHS, and Engineering to support operational readiness and ongoing ...
Manager, Quality Engineering
Rockville, MD · On-site
$116K - $177K/yr
Manage quality engineering team responsible for providing design control guidance and support for ... Experience working with FDA and/or ISO auditors is preferred. * Minimum of 2 years of management ...
Manager, Quality Engineering
Rockville, MD · On-site
$116K - $177K/yr
Manage quality engineering team responsible for providing design control guidance and support for ... Experience working with FDA and/or ISO auditors is preferred. * Minimum of 2 years of management ...
Manager, Quality Engineering
Rockville, MD · On-site
$116K - $177K/yr
Manage quality engineering team responsible for providing design control guidance and support for ... Experience working with FDA and/or ISO auditors is preferred. * Minimum of 2 years of management ...
Manager, Quality Engineering
Rockville, MD · On-site
$116K - $177K/yr
Manage quality engineering team responsible for providing design control guidance and support for ... Experience working with FDA and/or ISO auditors is preferred. * Minimum of 2 years of management ...
The ideal candidate will bring a robust engineering background, deep familiarity with FDA systems ... Expertise in Agile methodologies, quality control, and continuous improvement practices.
Quick apply
The ideal candidate will bring a robust engineering background, deep familiarity with FDA systems ... Expertise in Agile methodologies, quality control, and continuous improvement practices.
The ideal candidate will bring a robust engineering background, deep familiarity with FDA systems ... Expertise in Agile methodologies, quality control, and continuous improvement practices.
The ideal candidate will bring a robust engineering background, deep familiarity with FDA systems ... Expertise in Agile methodologies, quality control, and continuous improvement practices.
The ideal candidate will bring a robust engineering background, deep familiarity with FDA systems ... Expertise in Agile methodologies, quality control, and continuous improvement practices.
The ideal candidate will bring a robust engineering background, deep familiarity with FDA systems ... Expertise in Agile methodologies, quality control, and continuous improvement practices.
Senior Manager, Clinical Product Quality - Medical Device/Complaint Handling & Cardiovascular RN
Washington, DC · On-site +1
Provides medical/clinical guidance to complaint investigators and engineers related to event ... Reviews complaint codes and FDA Medical Device Reports, reviews and assists with reporting ...
Senior Manager, Clinical Product Quality - Medical Device/Complaint Handling & Cardiovascular RN
Washington, DC · On-site +1
Provides medical/clinical guidance to complaint investigators and engineers related to event ... Reviews complaint codes and FDA Medical Device Reports, reviews and assists with reporting ...
Commissioning Manager
Reston, VA · On-site
$125 - $150/hr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance * Ensure delivered systems meet contractual quality and performance ...
Commissioning Manager
Reston, VA · On-site
$125 - $150/hr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance * Ensure delivered systems meet contractual quality and performance ...
Ensure facility systems are compliant with GMP, FDA, and other applicable regulatory standards. Collaborate with Manufacturing, QA, EHS, and Engineering to support operational readiness and ongoing ...
Ensure facility systems are compliant with GMP, FDA, and other applicable regulatory standards. Collaborate with Manufacturing, QA, EHS, and Engineering to support operational readiness and ongoing ...
Commissioning Manager
Reston, VA · On-site
$105K - $160K/yr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance: * Ensure delivered systems meet contractual quality and performance ...
Commissioning Manager
Reston, VA · On-site
$105K - $160K/yr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance: * Ensure delivered systems meet contractual quality and performance ...
Production Engineer
$60K - $75K/yr
... FDA regulations, cGMP requirements, and company quality systems. * Initiate and support Change ... Mechanical Engineering * Industrial Engineering * Materials Science * Chemical Engineering
Production Engineer
$60K - $75K/yr
... FDA regulations, cGMP requirements, and company quality systems. * Initiate and support Change ... Mechanical Engineering * Industrial Engineering * Materials Science * Chemical Engineering
Production Engineer
Chantilly, VA · On-site
$60K - $75K/yr
... FDA regulations, cGMP requirements, and company quality systems. * Initiate and support Change ... Mechanical Engineering * Industrial Engineering * Materials Science * Chemical Engineering
Production Engineer
Chantilly, VA · On-site
$60K - $75K/yr
... FDA regulations, cGMP requirements, and company quality systems. * Initiate and support Change ... Mechanical Engineering * Industrial Engineering * Materials Science * Chemical Engineering
Production Engineer
Chantilly, VA · On-site
$60K - $75K/yr
... FDA regulations, cGMP requirements, and company quality systems. * Initiate and support Change ... Mechanical Engineering * Industrial Engineering * Materials Science * Chemical Engineering
Quick apply
Production Engineer
Chantilly, VA · On-site
$60K - $75K/yr
... FDA regulations, cGMP requirements, and company quality systems. * Initiate and support Change ... Mechanical Engineering * Industrial Engineering * Materials Science * Chemical Engineering
... GMP, FDA, and other applicable regulatory standards. • Collaborate with Manufacturing, QA, EHS, and Engineering to support operational readiness and ongoing facility improvements. • Lead or ...
... GMP, FDA, and other applicable regulatory standards. • Collaborate with Manufacturing, QA, EHS, and Engineering to support operational readiness and ongoing facility improvements. • Lead or ...
Commissioning Manager
Reston, VA · On-site
$105K - $160K/yr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance: * Ensure delivered systems meet contractual quality and performance ...
Quick apply
Commissioning Manager
Reston, VA · On-site
$105K - $160K/yr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance: * Ensure delivered systems meet contractual quality and performance ...
Commissioning Manager
Reston, VA · On-site
$105K - $160K/yr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance: * Ensure delivered systems meet contractual quality and performance ...
Commissioning Manager
Reston, VA · On-site
$105K - $160K/yr
Coordinate with engineering teams to resolve technical issues and ensure deliverables support ... Quality & Technical Assurance: * Ensure delivered systems meet contractual quality and performance ...
Office of Science and Engineering Laboratories (OSEL) Focus: Cardiovascular Device Mechanical ... FDA Regulations and Guidance * 21 CFR Part 820 - Quality System Regulation, as applicable to device ...
Office of Science and Engineering Laboratories (OSEL) Focus: Cardiovascular Device Mechanical ... FDA Regulations and Guidance * 21 CFR Part 820 - Quality System Regulation, as applicable to device ...
Contractual Quality Engineer Fda information
See Reston, VA salary details
$46.8K - $53.8K
1% of jobs
$53.8K - $60.8K
3% of jobs
$60.8K - $67.8K
7% of jobs
$67.8K - $74.8K
13% of jobs
$75.1K is the 25th percentile. Wages below this are outliers.
$74.8K - $81.8K
18% of jobs
The median wage is $84.7K / yr.
$81.8K - $88.8K
19% of jobs
$94.6K is the 75th percentile. Wages above this are outliers.
$88.8K - $95.8K
17% of jobs
$95.8K - $102.8K
9% of jobs
$102.8K - $109.8K
6% of jobs
$109.8K - $116.8K
4% of jobs
$116.8K - $123.8K
2% of jobs
$46.8K
$87.4K
$123.8K
How much do contractual quality engineer fda jobs pay per year?
What is the difference between Contractual Quality Engineer Fda vs Contract Quality Engineer?
| Aspect | Contractual Quality Engineer Fda | Contract Quality Engineer |
|---|---|---|
| Certifications | ISO 13485, FDA regulations, GMP | ISO 13485, FDA regulations, GMP |
| Work Environment | Medical device manufacturing, regulated environments | Medical device, pharmaceutical, or biotech industries |
| Employer Usage | Contract roles for FDA-regulated companies | Contract roles across various industries including pharma and biotech |
| Search Intent | Compare FDA-specific quality roles | Broader quality contract roles in regulated industries |
The Contractual Quality Engineer Fda focuses specifically on FDA regulations and medical device compliance, often working in regulated environments. The Contract Quality Engineer has a broader scope, covering various industries like pharma and biotech, with similar certifications. Both roles require knowledge of FDA standards, but the Contractual Quality Engineer Fda emphasizes FDA-specific compliance in medical devices.
What are the most commonly searched types of Quality Engineer Fda jobs in Reston, VA?
The most popular types of Quality Engineer Fda jobs in Reston, VA are:
QA specialist with Security Clearance
Silver Spring, MD • On-site
Other
Re-posted 26 days ago
Job description
Support implementation and continuous improvement of the ISO 15189 Quality Management System using Lean Six Sigma tools (DMAIC, FMEA, SPC, Value Stream Mapping).
Participate in CAP ISO assessments and manage nonconformance and corrective action tracking to ensure timely resolution.
Plan and conduct internal audits; document findings and follow up on corrective actions.
Perform risk assessments and assist in developing mitigation strategies.
Ensure compliance with regulatory requirements, including FDA regulations and LDT oversight.
Develop, update, and maintain quality policies, procedures, and document control systems.
Provide training to staff on ISO standards, quality tools, and compliance practices.
Prepare reports and quality metrics for leadership and support external audits and inspections. Qualifications:
Bachelor’s degree in Quality Engineering, Quality Management, Business, or related field required; Master’s or PhD preferred.
Certified Quality Auditor (CQA) and Lean Six Sigma Green Belt or higher preferred
5–7 years of experience in ISO 15189 quality programs, auditing, CAP ISO assessments, and risk management.
Knowledge of FDA regulations and laboratory compliance standards preferred.
Proficiency with compliance software and audit management tools.
This role requires strong analytical skills, attention to detail, and a commitment to maintaining high standards of quality and regulatory compliance.
About Ampcus
Sourced by ZipRecruiter
Ampcus Inc. is a ISO 20000, ISO 27000, ISO 9001, CMMI DEV/3 SM and CMMI SVC/3 SM certified global provider of a broad range of Technology and Business consulting services. From strategy to execution, our disciplined yet flexible approach starts and ends with our clients. By listening hard and working harder, client goals become our goals. Their success is our satisfaction. It’s why our clients sleep well at night. We believe that the success of an engagement is determined by strong project management, as well as clear communication and mutual commitment working collaboratively. Our methodology begins with listening to the customer about their needs, then working with their team to gain a clear understanding of the requirements, while providing knowledge transfer of best practices for the organization.
Industry
It services
Company size
1,001 - 5,000 Employees
Headquarters location
Chantilly, VA, US
Year founded
2004