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Systems Assurance Engineer Jobs (NOW HIRING)

Anika Systems

Quality Assurance Engineer

Leesburg, VA · On-site +1

Anika Systems is seeking a highly technical Quality Assurance Engineer with strong development, SQL, and Python expertise to support enterprise data platforms for federal clients. This is not a ...

Svitla Systems, Inc.

QA Engineer

Svitla Systems Inc. is looking for a QA Middle/Senior Engineer for a part-time (20-30 hrs/week) position with a path to full-time (40 hours per week) in the USA. Our client is a provider of an AI ...

Redolent, Inc

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One of our direct client is urgently looking for QA Engineer @ Sunnyvale, CA TITLE: QA Engineer ... This includes functional automation, performance testing, technical test automation and system ...

Nastech Global

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Cupertino, CA · On-site

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Apple

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The Apple Beats team is looking for a highly-motivated systems QA engineer to drive our multi-functional testing efforts across all our products. Quality is essential to the Beats Apple product ...

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ProScore Technologies

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Dynamed Solutions

Quality Assurance Engineer

Columbia, MD · On-site

$80K - $95K/yr

... healthcare system through improved patient care and outcomes, reduced costs, and data-driven ... The QA Engineer will work with developers, product managers, and other QA Engineers to ensure ...

Vertex Sigma Software

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uAvionix

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The Quality Assurance (QA) Engineer III/IV will implement, execute, and assist in management of the QA system, department, and staff. They will serve as a vital conduit between the manufacturing and ...

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How much do systems assurance engineer jobs pay per year?

As of Jun 20, 2026, the average yearly pay for systems assurance engineer in the United States is $177,719.00, according to ZipRecruiter salary data. Most workers in this role earn between $173,000.00 and $205,000.00 per year, depending on experience, location, and employer.

How does a Systems Assurance Engineer typically collaborate with cross-functional teams during a project lifecycle?

As a Systems Assurance Engineer, you will work closely with various teams such as design, development, quality assurance, and operations to ensure that system requirements and safety standards are met. Collaboration often involves participating in design reviews, coordinating verification and validation activities, and addressing any compliance or reliability concerns that arise. Effective communication and documentation skills are essential, as you may need to explain technical issues to non-technical stakeholders and ensure all parties are aligned on system goals and deliverables.

What are Systems Assurance Engineers?

Systems Assurance Engineers are professionals responsible for ensuring that complex systems, such as those used in industries like transportation, aerospace, or IT, meet required safety, reliability, and quality standards. They analyze system designs, identify potential risks or failures, and develop processes to mitigate these issues throughout the system's lifecycle. Their work often involves rigorous testing, compliance with industry regulations, and collaboration with other engineering teams to ensure products or systems are safe, effective, and dependable. Systems Assurance Engineers play a critical role in minimizing operational risks and ensuring project success.

What is the difference between Systems Assurance Engineer vs Systems Safety Engineer?

AspectSystems Assurance EngineerSystems Safety Engineer
CertificationsISO 9001, CMMI, Six SigmaISO 26262, IEC 61508, CSSE
Work EnvironmentDefense, aerospace, manufacturingAutomotive, aerospace, industrial
Industry UsageQuality assurance, system reliabilitySafety analysis, hazard mitigation

Systems Assurance Engineers focus on ensuring overall system reliability and quality, often through process improvement and compliance. Systems Safety Engineers concentrate on identifying and mitigating safety hazards within systems. While both roles require safety and quality certifications and work in similar industries, their primary focus areas differ: assurance emphasizes reliability, whereas safety emphasizes hazard prevention.

What are the key skills and qualifications needed to thrive as a Systems Assurance Engineer, and why are they important?

To thrive as a Systems Assurance Engineer, you need a strong background in systems engineering principles, quality assurance, and risk management, often supported by a degree in engineering or a related field. Familiarity with industry standards like ISO 9001, knowledge of requirements management tools (such as DOORS), and relevant certifications (e.g., INCOSE CSEP) are typically expected. Attention to detail, analytical thinking, and effective communication are crucial soft skills for collaborating with cross-functional teams and ensuring compliance. These capabilities are vital to identifying risks, maintaining system integrity, and delivering reliable, compliant solutions.
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What cities are hiring for Systems Assurance Engineer jobs? Cities with the most Systems Assurance Engineer job openings:
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Systems Assurance Engineer jobs near you
Infographic showing various Systems Assurance Engineer job openings in the United States as of June 2026, with employment types broken down into 89% Full Time, 10% Part Time, and 1% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $177,719 per year, or $85.4 per hour.

Director, Quality Engineering & Computer System Assurance

Serán BioScience

Bend, OR • On-site

Full-time

PTO

Posted 3 days ago

Job description

Serán BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization's validation, qualification, and computerized systems assurance programs. This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.
This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.
The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.
Duties and Responsibilities
Strategic Leadership
  • Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
  • Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
  • Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
  • Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs
  • Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie

Validation Lifecycle Oversight
  • Provides Quality leadership and oversight of validation programs including:
    • Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems

Key activities include:
  • Approval and oversight of validation lifecycle documentation including:
    • Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
  • Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
  • Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
  • Ensures validated systems maintain a continuous state of control throughout their operational lifecycle

Computer System Assurance (CSA) & Data Integrity
  • Supports the design and implementation of the organization's Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
  • Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
  • Oversees validation lifecycle management for computerized systems including:
    • Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
  • Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
  • Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
  • Supports system lifecycle activities including system upgrades, migrations, and decommissioning

Operational Quality Engineering Support
  • Provides QA oversight and approval for quality system elements impacting validated systems including:
    • Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systems
  • Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
  • Provides QA support for technology transfer, new product introductions, and site capital projects
  • Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
  • Supports troubleshooting of complex process or system issues impacting validated systems
  • Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
  • Leads preparation and inspection readiness programs related to validation and data integrity

Leadership & People Management
  • Leads and develops a high-performing Quality Engineering and CSA organization
  • Provides mentoring, coaching, and professional development for technical staff
  • Establish clear departmental goals aligned with organizational quality and operational objectives
  • Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
  • Fosters a culture of quality ownership, compliance, and continuous improvement

Required Knowledge and Skills
  • Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
  • Experience organizing and managing work responsibilities while working independently with minimal oversight
  • Deep expertise in Computer System Validation / Computer System Assurance
  • Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies
  • Time and project management skills with the ability to multi-task and meet deadlines
  • Excellent verbal and written communication skills
  • Excellent interpersonal and customer service skills
  • Excellent organizational skills and attention to detail
  • Strong analytical and problem-solving skills
  • Strong supervisory and leadership skills
  • Ability to prioritize tasks and to delegate them when appropriate
  • Willingness to accept feedback from a variety of sources
  • Ability to constructively manage conflict
  • Ability to collaborate and work in cross-functional teams
  • Ability to function well in a high-paced and at times stressful environment
  • Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
  • Proficient with Microsoft Office Suite or related software

Education and Experience
  • Bachelor's degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree
  • Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
  • Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity
  • Demonstrated experience with regulatory inspections by the FDA and EU authorities

Physical Requirements
  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Adheres to consistent and predictable in-person attendance

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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