Quality Assurance Specialist IV

BioSpace; Frederick (MD); On-site; USD 95,000 - 136,000; Full time

Job summary

Leidos Biomedical Research, Inc. operates the Frederick National Laboratory and seeks a QA Specialist IV to lead quality assurance for engineering, maintenance, and asset management.

You will ensure compliance with safety programs, regulatory standards, and continuous improvement initiatives. The role requires a Bachelor’s degree in a related field and at least eight years of applicable experience in QA, engineering quality, and facilities management.

Qualifications

• Bachelor’s degree from an accredited college/university in Engineering, Quality Management, Industrial Engineering, Facilities Management, Construction Management, Engineering Technology, or related field.
• Minimum of eight (8) years of related experience in quality assurance, engineering quality, facilities management, or a similar field.

Responsibilities

• Develop, implement, and maintain QA programs and standards for engineering and maintenance operations.
• Monitor compliance with engineering standards and QA systems.
• Serve as SME in quality systems, process compliance, risk assessment, and continuous improvement initiatives.
• Identify risks, recommend corrective actions, and collaborate across teams to improve quality and reliability.
• Review engineering plans and procedures for adherence to codes and standards.
• Ensure safety, environmental, regulatory, and quality compliance in facilities operations.
• Communicate QA performance indicators, audit results, and trends to leadership.
• Establish documentation controls to ensure traceability and regulatory alignment.
• Develop and maintain QA documentation, including procedures, standards, and audit reports.
• Support training on QA requirements and engineering standards.

Skills

Quality assurance

Audits

CAPA

Risk assessment

Documentation control

Continuous improvement

Regulatory compliance

Education

Bachelor’s degree in Engineering or related field

Job description

Job ID: req4712

Employee Type: exempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

Program Description

The Quality Assurance (QA) Specialist IV – Engineering is a senior-level professional responsible for developing, implementing, monitoring, and continuously improving quality assurance programs, standards, and processes that support engineering, maintenance, reliability, and asset management activities within the Facilities Maintenance & Engineering directorate. This position ensures compliance with organizational policies, engineering standards, regulatory requirements, safety programs, and industry best practices.

Key Roles And Responsibilities

• Develop, implement, maintain, and enhance quality assurance programs, policies, procedures, and standards supporting facilities such as engineering and maintenance operations.
• Monitor compliance with engineering standards, maintenance procedures, quality management systems, and organizational requirements.
• Serve as a subject matter expert in quality systems, engineering process compliance, risk assessment, performance auditing, and continuous improvement initiatives.
• Evaluate engineering and maintenance processes, identifies risks and deficiencies, recommends corrective and preventive actions, and collaborates with engineering, maintenance, operations, safety, and business teams to improve quality, reliability, and operational performance.
• Review engineering plans, specifications, procedures, and work processes to ensure adherence to applicable codes, regulations, and organizational standards.
• Monitor compliance with safety, environmental, regulatory, and quality requirements affecting facilities engineering operations.
• Monitor and communicate quality performance indicators, audit results, and compliance trends.
• Establish and maintain quality control processes to ensure consistency, reliability, and effectiveness of engineering and maintenance activities.
• Develop, review, and maintain quality-related documentation, including procedures, standards, work instructions, audit reports, and compliance records.
• Ensure document control processes support consistency, traceability, and regulatory requirements.
• Assist in the development and maintenance of engineering standards, technical procedures, and quality manuals.
• Facilitate and support training programs related to quality assurance requirements, engineering standards, compliance obligations, and operational procedures.
• Support the development of quality performance metrics, reporting tools, and continuous improvement initiatives.
• Facilitate continuous improvement initiatives focused on quality, reliability, efficiency, and process standardization.
• Promote a culture of quality, accountability, and operational excellence throughout the department.

Basic Qualifications

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in Engineering, Quality Management, Industrial Engineering, Facilities Management, Construction Management, Engineering Technology, or a related technical field. Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of eight (8) years of related experience in quality assurance, engineering quality, facilities management, maintenance operations, compliance, or a related field is required.
• Experience conducting audits, risk assessments, compliance reviews, and quality improvement initiatives.
• Experience working within engineering, facilities maintenance, construction, manufacturing, healthcare facilities, government facilities, or similarly regulated environments.
• Strong knowledge of quality assurance principles, quality management systems, and continuous improvement methodologies.
• Knowledge of engineering standards, facility operations, maintenance practices, asset management principles, and regulatory compliance requirements.
• Experience with root cause analysis, corrective and preventive action (CAPA) processes, and risk management frameworks.
• Ability to analyze complex technical and operational processes and identify improvement opportunities.
• Strong understanding of documentation control, audit processes, and compliance monitoring.
• Excellent written and verbal communication skills, including the ability to prepare reports and present findings to leadership.
• Strong organizational, analytical, and problem-solving skills.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• Ability to obtain and maintain a security clearance.

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

Preferred Certifications: Certified Quality Engineer CQE), or Certified Reliability Engineer (CRE).

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

95,100.00 - 136,400.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions