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Quality System Manager Jobs (NOW HIRING)

Delcath Systems Inc

Quality System Manager

Queensbury, NY · On-site

$120K - $140K/yr

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 ...

SEACORP

Quality System Manager

Norfolk, VA · On-site

SEACORP is seeking a well-qualified Quality System Manager . Primary Duties and Responsibilities: Job Summary : Plan, direct, and coordinate quality assurance administration programs of the company ...

Clark Pacific

Quality System Coordinator

Woodland, CA

$71K - $90K/hr

The Quality System Coordinator provides support to Quality System Managers and Quality Control Leads by utilizing organizational and analytical skills. They are well organized, detailed oriented ...

OSI Systems, Inc

Manager Quality Systems

Snoqualmie, WA · On-site

$150K - $175K/yr

Manage control of Quality Management System changes. * Manage the document control process. * Ensure staff training and competency to ensure adequate and effective QMS performance. * Facilitate ...

ARTHREX

Quality Systems Manager

Pendleton, SC · On-site

Mentors and coaches others in enhancing the Quality System, system's development and continuous ... Good project management skills. * Strict attention to detail. * Excellent communication skills are ...

Nextern

Quality Systems Manager

Maple Grove, MN · On-site

$120K - $140K/yr

The role is also responsible for the selection, implementation, administration, and monitoring of the Quality Management System ensuring continual compliance of the organization. The role owns the ...

Centor

Quality Senior Manager

Millersburg, OH

This role leads the Quality Management System (QMS), ensures compliance with applicable GMP standards for pharmaceutical packaging, and drives defect prevention in high-volume manufacturing processes.

GSMS

Quality System Associate

Camarillo, CA · On-site

$24.25/hr

Quality Systems Associate Summary: The Quality Systems Associate supports multiple quality ... This role performs RMA inspections, deviations and product complaint investigations, manages ...

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 ... Transverse, and/or specific management of an auditor team * Capacity to make decisions * The ...

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Quality System Manager information

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$54K

$98.6K

$154K

How much do quality system manager jobs pay per year?

As of Jun 9, 2026, the average yearly pay for quality system manager in the United States is $98,613.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,500.00 and $122,500.00 per year, depending on experience, location, and employer.

What is the difference between Quality System Manager vs Quality Assurance Manager?

AspectQuality System ManagerQuality Assurance Manager
CertificationsISO 9001 Lead Auditor, CQEASQ CQE, Six Sigma Green/Black Belt
Work EnvironmentOversees quality management systems across departmentsFocuses on product quality and testing processes
Industry UsageCommon in manufacturing, aerospace, automotivePrevalent in manufacturing, healthcare, software
Primary FocusMaintaining and improving quality management systemsEnsuring product quality through testing and inspection

The Quality System Manager primarily manages the overall quality management system, ensuring compliance with standards like ISO 9001. The Quality Assurance Manager concentrates on product quality, testing, and inspection processes. Both roles require similar certifications and are vital in manufacturing and related industries, but their focus areas differ—system oversight versus product quality assurance.

What are some common challenges faced by a Quality System Manager when implementing new quality standards across an organization?

Quality System Managers often encounter challenges such as resistance to change from staff, aligning new standards with existing processes, and ensuring consistent understanding across departments. Building strong communication channels and providing thorough training are essential to facilitate adoption. Additionally, maintaining regulatory compliance while tailoring the system to the organization's unique needs requires careful planning and collaboration with cross-functional teams.

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

To thrive as a Quality System Manager, you need a solid background in quality management principles, regulatory compliance, and process improvement, typically with a degree in engineering, life sciences, or a related field. Familiarity with ISO standards (e.g., ISO 9001), quality management software, and relevant certifications like Six Sigma or ASQ certifications is important. Strong leadership, problem-solving, and communication skills help drive cross-functional initiatives and foster a culture of continuous improvement. These skills ensure effective implementation of quality systems, compliance with industry standards, and sustained operational excellence.

What does a Quality System Manager do?

A Quality System Manager oversees the development, implementation, and maintenance of an organization's quality management systems. They ensure that all processes and products meet established quality standards and comply with relevant regulations. Their responsibilities include auditing processes, managing documentation, training staff on quality procedures, and driving continual improvement initiatives. By monitoring performance and addressing non-conformities, they help organizations deliver consistent, high-quality products or services.
More about Quality System Manager jobs
What cities are hiring for Quality System Manager jobs? Cities with the most Quality System Manager job openings:
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 Manager jobs? States with the most job openings for Quality System Manager jobs include:
Quality System Manager jobs near you
Infographic showing various Quality System Manager job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 87% Full Time, 7% Part Time, 1% Temporary, and 4% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $98,613 per year, or $47.4 per hour.
Quality System Manager

Quality System Manager

Delcath Systems Inc

Queensbury, NY • On-site

$120K - $140K/yr

Full-time

Medical, Retirement

Posted 16 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.