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Quality Systems Engineer Jobs (NOW HIRING)

SNAP Diagnostics

Quality Systems Engineer

Anderson, SC · On-site

The Quality Systems Engineer is responsible for maintaining and improving the company's Quality Management System (QMS) to ensure compliance with ISO standards, regulatory requirements, and internal ...

Universal Avionics

Quality Systems Engineer

Tucson, AZ · On-site

Quality Systems Engineer Tucson, AZ (Onsite) | Aerospace & Avionics 9/80 Schedule Available - Every Other Friday Off Quality Systems Engineer - Be the Backbone of Aerospace Excellence At Universal ...

OpSource Staffing

Quality Systems Engineer

Gaffney, SC · On-site

$32.69/hr

Quality Systems Engineer Pay: $68,000/yr. DOE Hours: 8am - 5pm or 7am -4pm (M-F) Location: Gaffney, SC Job Overview The Quality Systems Engineer is responsible for developing, maintaining and ...

New

OpSource Staffing

Quality Systems Engineer

Gaffney, SC · On-site

$68K/yr

Quality Systems Engineer Pay: $68,000/yr. DOE Hours: 8am - 5pm or 7am -4pm (M-F) Location: Gaffney, SC Job Overview The Quality Systems Engineer is responsible for developing, maintaining and ...

New

Black Clawson

Quality Systems Engineer

Lebanon, OH · On-site

The Quality Systems Engineer performs supplier site inspections and audits to determine if products meet KBC and customer requirements, all while advancing KBC's mission of being a forward-thinking ...

EHC

Quality Systems Engineer

Houston, TX

$86K - $96K/yr

Quality Systems Engineers are exposed to multiple facets of our dredging projects with responsibilities for safety, quality control, quality assurance, documentation, and supporting the project team ...

THINK Surgical, Inc.

Quality Systems Engineer

Fremont, CA · On-site

$112K - $127K/yr

JOB SUMMARY The Quality System Engineer is responsible for supporting the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), with a primary focus on CAPA ...

nudge

Quality Systems Engineer

San Francisco, CA · On-site

About the role As a quality systems engineer at Nudge, you will: * Ensure that new and existing product designs and processes meet all internal and regulatory requirements with respect to safety and ...

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How much do quality systems engineer jobs pay per hour?

As of Jun 4, 2026, the average hourly pay for quality systems engineer in the United States is $50.03, according to ZipRecruiter salary data. Most workers in this role earn between $38.46 and $54.09 per hour, depending on experience, location, and employer.

What Does a Quality Systems Engineer Do?

A quality systems engineer conducts frequent and detailed quality checks to make sure the products and processes in a manufacturing setting are consistent and meet both industry and client standards as well as legal demands. In this role, you may monitor processes in various industries, so job duties can vary. However, you always play a role in locating and fixing defects. You check tools and materials, conduct tests, and train employees to meet safety requirements. You also closely document any problems for the engineer, who finds a solution. You follow the entire manufacturing process from beginning to end. In this job, you may work in a lab or an office.

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

To thrive as a Quality Systems Engineer, you need a solid background in quality management principles, process improvement methodologies, and a degree in engineering or a related field. Familiarity with ISO standards, Six Sigma or Lean certifications, and experience with quality management systems (QMS) software are typically required. Strong analytical thinking, attention to detail, and effective communication skills help you excel in cross-functional teams and drive quality initiatives. These competencies ensure compliance, continuous improvement, and the delivery of high-quality products or services.

How does a Quality Systems Engineer typically collaborate with cross-functional teams within an organization?

Quality Systems Engineers often work closely with various departments such as production, engineering, regulatory affairs, and supply chain to ensure that quality management systems are effectively implemented and maintained. They facilitate communication among teams to address compliance issues, resolve process deviations, and implement continuous improvement initiatives. Regular meetings, audits, and training sessions are common ways they collaborate to uphold quality standards and meet regulatory requirements. This collaborative approach helps ensure that quality objectives are integrated throughout all stages of the product lifecycle.

What are Quality Systems Engineers?

Quality Systems Engineers are professionals responsible for designing, implementing, and maintaining quality management systems within an organization. They ensure that products or services meet established standards and regulatory requirements by developing processes, conducting audits, and analyzing data to identify areas for improvement. Their role often involves collaborating with other departments, training staff on quality procedures, and ensuring compliance with industry certifications such as ISO 9001. By maintaining effective quality systems, they help organizations deliver consistent, high-quality outcomes and reduce the risk of defects or non-conformance.

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

AspectQuality Systems EngineerQuality Assurance Engineer
CertificationsISO 9001, Six Sigma, ASQ certificationsISO 9001, Six Sigma, ASQ certifications
Work EnvironmentManufacturing, aerospace, automotive, medical devicesManufacturing, software, healthcare, consumer products
ResponsibilitiesDeveloping and maintaining quality management systems, ensuring compliance, process improvementTesting products, identifying defects, ensuring product quality before release

While both roles focus on quality, the Quality Systems Engineer primarily develops and maintains quality management systems and processes, ensuring compliance across the organization. The Quality Assurance Engineer concentrates on testing products and identifying defects to ensure product quality before reaching customers. Both roles often collaborate but serve different stages of the quality management lifecycle.

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Quality Systems Engineer jobs near you
Infographic showing various Quality Systems Engineer job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 88% Full Time, 6% Part Time, 1% Temporary, and 4% Contract. Highlights an 86% Physical, 5% Hybrid, and 9% Remote job distribution, with an average salary of $104,058 per year, or $50 per hour.
Quality Systems Engineer

Quality Systems Engineer

Delcath Systems Inc

Queensbury, NY • On-site

$80K - $100K/yr

Full-time

Medical, Retirement

Posted 10 days ago

Job description

We’re looking for a motivated and collaborative Quality Systems Engineer to join our growing team at Delcath. In this role, you’ll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment.

We're excited to provide a complete benefits package, including a comprehensive health plan, 401(k), and professional development opportunities, to support the well-being and growth of our employees and their families.

POSITION SUMMARY
The Quality Systems Engineer is responsible for routine management and coordination of the Delcath Documentation Quality System. The overall purpose of the position is to ensure that FDA, EU GMP and ISO 13485 Quality System requirements and Company procedures are followed, and, if needed, that Company procedures are revised for compliance.

The Quality Systems Engineer must demonstrate a high level of involvement in continuous improvement activities to ensure the highest standards are maintained. The Quality Systems Engineer must possess ability to solve practical problems and deal with a variety of situations in a fast-paced environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required.
  • Manages the Document Change control process (ECN); development, approval, issuance, revision, distribution, maintenance, use, storage, security, and disposal of critical Delcath documents (specifications, procedures, work instructions, labeling) for the Queensbury and Galway sites.
  • Responsible for managing external standards.
  • Manages/supports the Supplier program.
  • System administrator for the Document Management System
  • Supports quality systems software validations.
  • Supports technical file maintenance and submissions to Notified Body.
  • Manages the preparation, submission, and maintenance of all labeling/labeling-related projects.
  • Maintain archive of change-controlled labeling including creation of summary of change or labeling annotations to be used in the change control process and maintained in labeling archive for submission to regulatory agencies.
  • Coordinates the annual review of all controlled documentation.
  • Creates/revises BOMs and Routings in ERP system.
  • Responsible for issuing Training requirements through the Document Management System.
  • Support the Corrective Action and Preventive Action program and NCR program.
  • Supports the Internal Audit Program and performance of audits as required.
  • Support external audits.
  • Support Management Review process to monitor and evaluate Quality System effectiveness.
  • Develop and maintain a working knowledge of FDA cGMP and 21CFR 820 regulations and Clinical trial (EU) regulation 536/2014 supplemented by GMP regulation 2017/1569 and EU GMP guidelines for IMPs (December 2017).
  • Support Post Market Surveillance program.
  • Support quality and regulatory projects.

SUPERVISORY RESPONSIBILITIES
The Quality Systems Engineer has no supervisory responsibilities.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, unless they constitute undue hardship.

EDUCATION and/or EXPERIENCE

  • A minimum of a bachelor’s degree in engineering or physical sciences is required.
  • A minimum of three or more years of experience in quality assurance of an FDA regulated or ISO 13485 certified organization.
  • Must possess strong knowledge of computerized Document Control Systems.
  • Must have experience in audit support, document control, change control, CAPA, NCR.
  • Certification in internal/external auditing an advantage
  • Ideally have auditor experience and auditor certification.
  • Must be team oriented, with the ability to work well with diverse cross-functional teams.
  • Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.
  • Must possess strong verbal and written communication skills.
  • Must be willing to travel on occasion.

LANGUAGE SKILLS
Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with employees and outside organizations.

MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.