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Quality System Specialist Jobs (NOW HIRING)

Mary Dickson

Sr Quality Systems Specialist

Newark, DE · On-site

$85K - $133K/yr

Senior Quality Systems Specialist Newark, DE, United States Marlborough, MA, United States Hologic ... Understanding of GMP concepts and quality system processes such as Quality Agreements, Quality ...

CooperVision Limited

NY · On-site

Provide specialist knowledge and support to Quality Operations management and other business ... Acts as the QA systems representative and participates with cross functional teams on significant ...

System One

Quality Management Systems Specialist

Cary, IL · Remote

$50 - $55/hr

Job Title: Quality Management Systems Specialist Location: Cary, Illinois Type: Contract ... Develop and revise quality system documentation including procedures, work instructions, and change ...

System One

Quality Management Systems Specialist

Cary, IL · Remote

$50 - $55/hr

Job Title: Quality Management Systems Specialist Location: Cary, Illinois Type: Contract ... Develop and revise quality system documentation including procedures, work instructions, and change ...

System One

Quality Management Systems Specialist

Cary, IL · Remote

$50 - $55/hr

Job Title: Quality Management Systems Specialist Location: Cary, Illinois Type: Contract ... Develop and revise quality system documentation including procedures, work instructions, and change ...

System One

Quality Management Systems Specialist

Cary, IL · Remote

$50 - $55/hr

Job Title: Quality Management Systems Specialist Location: Cary, Illinois Type: Contract ... Develop and revise quality system documentation including procedures, work instructions, and change ...

System One

Quality Management Systems Specialist

Cary, IL · Remote

$50 - $55/hr

Job Title: Quality Management Systems Specialist Location: Cary, Illinois Type: Contract ... Develop and revise quality system documentation including procedures, work instructions, and change ...

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Quality System Specialist information

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How much do quality system specialist jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for quality system specialist in the United States is $34.38, according to ZipRecruiter salary data. Most workers in this role earn between $27.16 and $39.66 per hour, depending on experience, location, and employer.

What is a quality system specialist?

Quality System Specialists are professionals responsible for developing, implementing, and maintaining quality management systems within an organization. Their primary role is to ensure that products or services meet established quality standards and comply with regulatory requirements. They often perform audits, analyze processes, and coordinate corrective actions to improve quality and efficiency. Quality System Specialists typically work in industries such as manufacturing, pharmaceuticals, and healthcare, where adherence to quality standards is critical.

What are the key skills and qualifications needed to thrive as a quality system specialist?

To thrive as a Quality System Specialist, you need a strong understanding of quality management principles, regulatory requirements, and process improvement, typically supported by a degree in science, engineering, or a related field. Familiarity with ISO standards, CAPA systems, document control software, and relevant quality certifications such as Six Sigma or ASQ are commonly required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for this role. These competencies ensure robust quality systems, regulatory compliance, and continuous improvement within an organization.

What are some common challenges quality system specialists face when implementing new quality procedures across departments?

Quality System Specialists often encounter challenges such as resistance to change from staff, varying levels of understanding of quality standards, and aligning procedures with existing workflows. Effective communication, thorough training, and collaboration with cross-functional teams are essential to ensure smooth adoption of new processes. Additionally, regularly gathering feedback and adjusting procedures as needed helps address concerns and improve overall compliance.

What is the difference between Quality System Specialist vs Quality Assurance Coordinator?

AspectQuality System SpecialistQuality Assurance Coordinator
CertificationsISO 9001 Lead Auditor, CQEISO 9001 Lead Auditor, CQE
Work EnvironmentManufacturing, healthcare, or tech companies focusing on quality management systemsManufacturing, healthcare, or tech companies overseeing quality processes
Employer & Industry UsageUsed in industries implementing quality management systemsUsed in industries ensuring product/service quality compliance

The main difference is that a Quality System Specialist focuses on developing, maintaining, and improving quality management systems, ensuring compliance with standards like ISO 9001. In contrast, a Quality Assurance Coordinator primarily oversees day-to-day quality assurance activities, inspections, and testing to ensure products meet quality standards. Both roles require similar certifications and often work in the same industries, but their focus areas differ within the quality management framework.

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Quality System Specialist jobs near you
Infographic showing various Quality System Specialist 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 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $71,505 per year, or $34.4 per hour.

Quality Engineer / Quality Systems Specialist

Durham, NC • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 3 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Quality Engineer/Quality Systems Specialist position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: Contract Quality Engineer / Quality Systems Specialist

Location: Durham, NC
Duration: Long Term
 

Job Overview

We are seeking an experienced Quality Engineer / Quality Systems Specialist to support a fast-paced FDA-regulated medical device manufacturing environment. This role will focus on driving CAPAs, Non-Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements.

Key Responsibilities

  • Manage and drive CAPAs and Non-Conformance investigations to timely closure.
  • Support Complaint Handling, Audit Readiness, and Risk Management activities.
  • Conduct root cause investigations and implement effective corrective and preventive actions.
  • Ensure compliance with FDA regulations, ISO 13485, and internal Quality System requirements.
  • Collaborate with Manufacturing, Engineering, and Quality teams to resolve quality issues.
  • Support continuous improvement initiatives and maintain Quality Systems documentation.

Required Qualifications

  • Experience in Quality Engineering or Quality Systems within the Medical Device industry.
  • Hands-on experience with CAPA, Non-Conformances, Complaints, Audits, and Risk Management.
  • Strong knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
  • Proven root cause analysis and investigation experience.
  • Excellent problem-solving, communication, and documentation skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com