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Quality Systems Leader Jobs (NOW HIRING)

Actalent

Quality Systems Specialist

San Mateo, CA

Quality Systems Training Specialist The Quality Systems Training Specialist supports Product ... Partner with Subject Matter Experts, Business Process Owners, and Functional Leaders to assess ...

Unifin SAS

Quality Systems Manager

Rochester, NY · On-site

The Quality Systems Manager oversees the process and management of systems, deviation management ... This position interacts with everyone (leadership team, managers, operators...) and must have a ...

Spirax-Sarco Ltd.

Quality Systems Specialist

Devens, MA · On-site

TheQuality Systems specialist plays a critical role in governing quality processes, leading audits, ensuring ISO compliance, and embedding quality requirements across all site functions. The role ...

Covetrus, Inc.

Quality Systems Engineer

Covetrus is a global animal-health technology and services leader dedicated to empowering ... Summary The Quality Systems Engineer (Automation & AI Focus) is responsible for designing, building ...

Astemo Ltd

Quality Systems Engineer

Monroe, GA · On-site

Oversee the Quality System auditing function to include audit schedule management, audit team ... Excellent communications and interpersonal skills, including demonstrated leadership ability and ...

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$54K

$98.6K

$154K

How much do quality systems leader jobs pay per year?

As of Jun 7, 2026, the average yearly pay for quality systems leader 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 Systems Leader vs Quality Assurance Manager?

AspectQuality Systems LeaderQuality Assurance Manager
Primary FocusOversees the development, implementation, and maintenance of quality management systems and compliance standardsEnsures product quality through testing, inspection, and process audits
CertificationsISO 9001 Lead Auditor, CQE, or similarASQ CQE, Six Sigma, or related certifications
Work EnvironmentStrategic, cross-departmental, compliance-drivenOperational, production-focused, quality testing labs
Employer & Industry UsageManufacturing, healthcare, aerospace, heavily regulated industriesManufacturing, pharmaceuticals, consumer goods

The Quality Systems Leader primarily manages the quality management system and ensures regulatory compliance across the organization, while the Quality Assurance Manager focuses on product quality through testing and inspection. Both roles require similar certifications and are vital in quality-driven industries, but their scope and daily responsibilities differ.

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

To thrive as a Quality Systems Leader, you need expertise in quality management systems (such as ISO 9001), regulatory compliance, and process improvement, often backed by a degree in engineering, science, or a related field. Familiarity with tools like CAPA (Corrective and Preventive Action), document control software, and certifications such as Six Sigma or ASQ Certified Quality Auditor are typically required. Strong leadership, analytical thinking, and effective communication skills set outstanding leaders apart by enabling them to drive quality culture and manage cross-functional teams. These skills ensure robust compliance, continuous improvement, and the delivery of high-quality products or services.

What is a Quality Systems Leader?

A Quality Systems Leader is a professional responsible for developing, implementing, and maintaining quality management systems within an organization. They ensure that the company's products or services meet established standards, regulatory requirements, and customer expectations. This role often involves leading teams, conducting audits, training staff, and driving continuous improvement initiatives to enhance overall quality performance. Quality Systems Leaders play a critical part in risk management and compliance, making sure processes are both efficient and effective.

What are the main challenges faced by a Quality Systems Leader when implementing new quality management processes?

One of the main challenges for a Quality Systems Leader is ensuring company-wide adoption and compliance with new quality management processes. This often involves addressing resistance to change, standardizing procedures across departments, and providing effective training for staff. Additionally, balancing regulatory requirements with operational efficiency requires careful planning and ongoing communication with cross-functional teams. Successful Quality Systems Leaders leverage strong project management and interpersonal skills to overcome these obstacles and drive continuous improvement.
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Quality Systems Leader jobs near you
Infographic showing various Quality Systems Leader job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 74% Full Time, 20% Part Time, and 5% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $98,613 per year, or $47.4 per hour.
Quality Systems Engineer

Quality Systems Engineer

Spectrum Plastics Group

Pleasant Prairie, WI

Full-time

Posted yesterday

Job description

The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. This role plays a key part in supporting internal and external audits, overseeing document control and CAPA processes, and driving continuous improvement initiatives across the organization. The engineer will collaborate with cross-functional teams to identify and implement quality system improvements, ensuring alignment with regulatory requirements and industry standards. With a strong focus on compliance, process optimization, and risk mitigation, this position is critical in supporting the company’s goal of delivering high-quality products while maintaining a culture of operational excellence and regulatory readiness.

  • Act as a role model and ensure safety is built into our QMS and work processes.
  • Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820.
  • Ensure compliance with ISO 13485 and 21 CFR Part 820 by providing regulatory guidance, conducting gap analyses, and leading corrective actions to close compliance gaps.
  • Design and improve quality assurance and control procedures, continuously optimizing the QMS to enhance regulatory compliance.
  • Investigate and resolve non-conformances, implementing corrective and preventive actions (CAPA) to mitigate risks and improve product quality.
  • Lead or participate in internal audits, identifying gaps and implementing necessary improvements to maintain audit readiness.
  • Apply problem-solving methodologies to prioritize and resolve quality issues promptly.
  • Utilize Six Sigma and other quality tools to reduce process variation and enhance product quality.
  • Monitor quality data and trends, providing recommendations to reduce defects and improve quality performance.
  • Provide training to employees on quality system requirements to ensure compliance and consistency across departments.
  • Collaborate with cross-functional teams to drive continuous improvements and optimize the effectiveness of the QMS.
  • Assist in preparing for and supporting external audits, inspections, and regulatory assessments, ensuring that the company remains audit ready.
  • Drive quality system enhancements, identifying and implementing improvement opportunities across the organization.
  • Other duties as required.
  • A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field.
  • 3-5 years of experience in quality system management within a medical device or other regulated environment.
  • Strong knowledge of FSSC 22000, ISO 9001, ISO 13485, 21 CFR Part 820, and industry best practices for QMS.
  • Proficient in CAPA processes, risk management strategies, and both internal and external audit processes.
  • Demonstrated ability to use QMS software and document control systems to manage regulatory documentation.
  • Excellent problem-solving, analytical, and troubleshooting skills.
  • Strong verbal and written communication abilities, capable of interacting with all levels of the organization.
  • Experience with Six Sigma or other process improvement methodologies to drive quality enhancements.

Ability to work collaboratively in cross-functional teams to ensure successful quality initiatives and improvements.

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