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Quality System Jobs (NOW HIRING)

Delcath Systems Inc

Quality System Manager

Queensbury, NY · On-site

$120K - $140K/yr

  • Medical

  • Retirement

We're looking for a motivated and collaborative Quality Systems Manager to join our growing team at Delcath. In this role, you'll have the opportunity to make a meaningful impact while working ...

McKesson

Quality System Specialist

Richmond, VA

The eQMS System Administrator partners closely with Quality, Regulatory, IT, and crossfunctional stakeholders to develop and maintain workflows for Complaints, CAPA, Change Control, Training ...

ZEISS

Quality System Manager

Dublin, CA · On-site

$132K - $165K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The Quality Systems Manager is responsible for developing, implementing, and maintaining the company's Quality Management Systems (QMS) to ensure compliance with applicable standards. The primary ...

Hitachi

Quality System Technician

Jefferson City, MO · On-site

As a Quality Systems Technician , you'll help maintain and improve our Quality Management System (QMS), support audits, manage document control activities, and drive corrective action processes that ...

Stellantis

Quality System Auditor

Auburn Hills, MI · On-site

As part of the Quality Policy, the system auditor must: * Carry out quality audits in the Company's Domains based on the QMS standards; advise auditees for improving operating methods, to ensure the ...

Hitachi

Quality System Analyst

Jefferson City, MO

As a Quality Systems Analyst , you will play an important role in maintaining and enhancing our Quality Management System (QMS), helping ensure compliance, operational excellence, and continuous ...

AAON, Inc.

Quality System Analyst

Longview, TX · On-site

Maintain product quality through audits, identify issues, and contribute to continuous improvement efforts Essential Job Duties and Responsibilities: * Collaborates with production, engineering, and ...

BALT Group

Quality System Engineer II

Irvine, CA · On-site

About this opportunity - Quality System Engineer II Description The Quality System Quality Engineer II will be responsible for supporting Balt USA's quality system including, but not limited to ...

Werfen

Quality System Specialist I

Bedford, MA · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management ...

The Jackson Laboratory

Quality System Manager - Remote

$85.99 - $130K/hr

Develop and implement continuous quality improvements in systems to reduce complexity, improve effectiveness, efficiencies and productivity and ensure sustainability and globalization * Develop and ...

Cummins Inc.

Quality System Technician II

Manning, SC

$16.75 - $22.50/hr

Plan, perform, and lead Quality Management System (QMS) audits in accordance with IATF 16949 and ISO 9001 standards. * Utilize and maintain QMS tools and systems to support quality compliance and ...

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Quality System information

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How much do quality system jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for quality system in the United States is $25.64, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $28.85 per hour, depending on experience, location, and employer.

What is a quality system?

Quality System jobs involve developing, implementing, and maintaining the processes and standards that ensure a company’s products or services meet regulatory and customer requirements. Professionals in these roles often work with quality management systems (QMS), conduct audits, and ensure compliance with industry regulations like ISO standards. They play a key role in continuous improvement by identifying areas for enhancement and working with other teams to resolve quality-related issues. Quality System jobs are vital across industries such as manufacturing, healthcare, and pharmaceuticals to guarantee product safety, reliability, and effectiveness.

What skills and qualifications are needed to thrive as a quality systems specialist?

To thrive as a Quality Systems Specialist, you need a strong understanding of quality management principles, regulatory standards (such as ISO 9001), and typically a degree in engineering, life sciences, or a related field. Familiarity with quality management software (QMS), document control systems, and relevant certifications like Six Sigma or ASQ are commonly required. Attention to detail, problem-solving abilities, and strong communication skills help ensure compliance and continuous improvement. These skills are essential to maintain product quality, meet regulatory requirements, and support organizational excellence.

What are common challenges faced by professionals working in quality systems, and how can they be addressed?

Professionals in Quality Systems often encounter challenges such as ensuring compliance with evolving regulatory standards, maintaining thorough documentation, and fostering a culture of continuous improvement across departments. Addressing these challenges typically involves staying updated on industry regulations, implementing effective training programs, and utilizing robust digital tools for document management. Additionally, strong communication and collaboration with cross-functional teams are essential to align quality objectives with broader organizational goals.

What is the difference between Quality System vs Quality Assurance?

AspectQuality SystemQuality Assurance
DefinitionFramework of policies, processes, and procedures to ensure quality management across an organization.Part of the quality system focused on preventing defects through planned activities and systematic processes.
FocusOverall quality management and compliancePreventing defects and ensuring product/service quality
CertificationsISO 9001, QS-9000ISO 9001, Six Sigma, CQA
Work EnvironmentCross-departmental, organizational-wideSpecific to quality processes and audits

In summary, a Quality System encompasses the entire framework for managing quality within an organization, including policies and procedures. Quality Assurance is a key component of the Quality System, focusing specifically on preventing defects and ensuring quality through systematic activities.

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What are the most commonly searched types of Quality System jobs?

The most popular types of Quality System jobs are:

What states have the most Quality System jobs?

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Quality System jobs near you
Infographic showing various Quality System job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $53,326 per year, or $25.6 per hour.

Quality System Manager

Delcath Systems Inc

Queensbury, NY • On-site

$120K - $140K/yr

Full-time

Medical, Retirement

Re-posted 26 days ago

Job description

We're looking for a motivated and collaborative Quality Systems Manager 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

Responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable national and international regulations and standards. Responsible for maintaining the quality system in an audit ready state.

This position retains signatory authority for Quality Management.

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

  • In coordination with Director of Quality, develops and executes quality and regulatory strategies and systems to comply with Quality System Regulations (QSR), Medical Device Regulation (EU MDR 2017/745), International Standards Organization (ISO), Recognized Consensus Standards and all other applicable quality system requirements. Ensures compliance to 21 CFR Part 820, 21 CFR Part 211, 21 CFR Part 4, ISO 13485, UK MDR 2002, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Manages and maintains the effectiveness of the Delcath Quality Management System and manages the resolution of all quality concerns and related issues as required.
  • Execute day-to-day processes for medical device manufacturing facility regulatory accountabilities to ensure continual regulatory compliance with FDA, Outside US Regulatory Authorities, and Notified Body and Approved Body requirements.
  • Lead Regulatory/Notified Body audits at the Queensbury site and provides support for Regulatory/Notified body audits at the Galway site
  • Manages the Corrective Action and Preventive Action Program.
  • Manages the Internal Audit Program.
  • Manage the Supplier Quality Program.
  • Support Customer Complaint investigations. Ensure Customer Complaint records are properly maintained, followed-up, and closed.
  • Manages the Management Review process to monitor and evaluate Quality System effectiveness.
  • Support the Post Market Surveillance process for the US and OUS markets.
  • Maintains current knowledge base of all regulatory and quality assurance related changes within the industry.
  • Monitor, review and interpret new or revised medical device regulatory requirements and proactively advise colleagues.
  • Supports new OUS country product registrations and manages existing country registration activities.
  • Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; appropriately document regulatory disposition of such changes. Manages these change notifications with the Notified Body and Approved Body.
  • Review and maintain Quality Systems programs and provide Site Regulatory SOPs to support business activities.


SUPERVISORY RESPONSIBILITIES

Manages employees and is responsible for the overall direction, coordination and evaluation. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

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 Bachelor’s degree in engineering or physical sciences.
  • Experience leading FDA / Notified body audits, ideally as the main point of contact.
  • A minimum of ten or more years of experience in quality systems, in an FDA regulated industry and ISO certified organization is required.
  • Experience of EU MDR regulation and management of quality systems that comply to same.
  • A minimum of three years’ people management experience and must be team oriented, with the ability to work well with diverse cross-functional teams to ensure company objectives are met.
  • Must possess strong analytical and process skills, and be computer proficient in Mastercontrol, EXCEL, Word, etc.
  • Must possess strong verbal and written communication skills.
  • Must be willing to travel.

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.