Quality Systems Engineer, Senior Department: Quality Employment Type: Full Time Location: Gainesville, FL Reporting To: Director Quality Management Systems Description The Quality Systems Engineer ...
Quality Systems Engineer, Senior Department: Quality Employment Type: Full Time Location: Gainesville, FL Reporting To: Director Quality Management Systems Description The Quality Systems Engineer ...
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and ...
New
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and ...
New
Job Details/Responsibilities Quality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive ...
Job Details/Responsibilities Quality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive ...
Job Details/Responsibilities Quality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive ...
Job Details/Responsibilities Quality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive ...
Quality System Engineer
Jupiter, FL ยท On-site
Quality System Engineer - CAR LOCATION: Jupiter, FL STATUS: Salary-exempt JOB SUMMARY The position ... systems (eDMS). * Lead or actively support training activities related to the QMS, business ...
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Quality System Engineer
Jupiter, FL ยท On-site
Quality System Engineer - CAR LOCATION: Jupiter, FL STATUS: Salary-exempt JOB SUMMARY The position ... systems (eDMS). * Lead or actively support training activities related to the QMS, business ...
Quality System Engineer
Jupiter, FL ยท On-site
Quality System Engineer LOCATION: Jupiter, FL STATUS: Salary-exempt JOB SUMMARY The position is ... systems (eDMS). * Lead or actively support training activities related to the QMS, business ...
Quick apply
Quality System Engineer
Jupiter, FL ยท On-site
Quality System Engineer LOCATION: Jupiter, FL STATUS: Salary-exempt JOB SUMMARY The position is ... systems (eDMS). * Lead or actively support training activities related to the QMS, business ...
Administers and oversee all ISO 9001:2015 quality system requirements related to all sites as required. * Work with engineering to validate the Electronic department processes and resources are being ...
Administers and oversee all ISO 9001:2015 quality system requirements related to all sites as required. * Work with engineering to validate the Electronic department processes and resources are being ...
Administers and oversee all ISO 9001:2015 quality system requirements related to all sites as required. * Work with engineering to validate the Electronic department processes and resources are being ...
Administers and oversee all ISO 9001:2015 quality system requirements related to all sites as required. * Work with engineering to validate the Electronic department processes and resources are being ...
... quality standards. * Provide technical input to program leadership and assist in stakeholder ... Bachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer ...
... quality standards. * Provide technical input to program leadership and assist in stakeholder ... Bachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer ...
Systems Engineer
Tampa, FL ยท On-site
Odyssey Systems is seeking a Systems Engineer to support advanced situational awareness and multi ... quality standards. * Provide technical input to program leadership and assist in stakeholder ...
Systems Engineer
Tampa, FL ยท On-site
Odyssey Systems is seeking a Systems Engineer to support advanced situational awareness and multi ... quality standards. * Provide technical input to program leadership and assist in stakeholder ...
Systems Engineer
Tampa, FL ยท On-site
... quality standards. * Provide technical input to program leadership and assist in stakeholder ... Bachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer ...
Systems Engineer
Tampa, FL ยท On-site
... quality standards. * Provide technical input to program leadership and assist in stakeholder ... Bachelor's degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer ...
Position Summary The Quality Systems / Technical Documentation Specialist is responsible for ... This position supports manufacturing, engineering, and quality teams by administering document ...
New
Position Summary The Quality Systems / Technical Documentation Specialist is responsible for ... This position supports manufacturing, engineering, and quality teams by administering document ...
New
Position Summary The Quality Systems / Technical Documentation Specialist is responsible for ... This position supports manufacturing, engineering, and quality teams by administering document ...
Position Summary The Quality Systems / Technical Documentation Specialist is responsible for ... This position supports manufacturing, engineering, and quality teams by administering document ...
Systems Engineer, Lead
Orlando, FL ยท Hybrid
$150K - $180K/yr
Mentor systems engineers and promote disciplined engineering methods, model quality, and technical rigor across the team. THIS HYBRID POSITION REQUIRES 3 DAYS OF WORK IN THE OFFICE AND 2 DAYS REMOTE ...
Systems Engineer, Lead
Orlando, FL ยท Hybrid
$150K - $180K/yr
Mentor systems engineers and promote disciplined engineering methods, model quality, and technical rigor across the team. THIS HYBRID POSITION REQUIRES 3 DAYS OF WORK IN THE OFFICE AND 2 DAYS REMOTE ...
Systems Engineer, Lead
Orlando, FL ยท On-site
$96.80 - $161.50/hr
Mentor systems engineers and promote disciplined engineering methods, model quality, and technical rigor across the team. THIS HYBRID POSITION REQUIRES 3 DAYS OF WORK IN THE OFFICE AND 2 DAYS REMOTE ...
Systems Engineer, Lead
Orlando, FL ยท On-site
$96.80 - $161.50/hr
Mentor systems engineers and promote disciplined engineering methods, model quality, and technical rigor across the team. THIS HYBRID POSITION REQUIRES 3 DAYS OF WORK IN THE OFFICE AND 2 DAYS REMOTE ...
Systems Engineer, Lead
Orlando, FL ยท On-site +1
$150K - $180K/yr
Mentor systems engineers and promote disciplined engineering methods, model quality, and technical rigor across the team. THIS HYBRID POSITION REQUIRES 3 DAYS OF WORK IN THE OFFICE AND 2 DAYS REMOTE ...
Systems Engineer, Lead
Orlando, FL ยท On-site +1
$150K - $180K/yr
Mentor systems engineers and promote disciplined engineering methods, model quality, and technical rigor across the team. THIS HYBRID POSITION REQUIRES 3 DAYS OF WORK IN THE OFFICE AND 2 DAYS REMOTE ...
Quality Systems & Compliance Manager
$90K - $120K/yr
Engineering Support * Compliance * Document Control * Continuous Improvement * Experience working within an ISO 9001 Quality Management System * Strong technical writing and documentation skills
Quality Systems & Compliance Manager
$90K - $120K/yr
Engineering Support * Compliance * Document Control * Continuous Improvement * Experience working within an ISO 9001 Quality Management System * Strong technical writing and documentation skills
Quality Systems & Compliance Manager
Fort Lauderdale, FL ยท On-site
$90K - $120K/yr
Engineering Support * Compliance * Document Control * Continuous Improvement * Experience working within an ISO 9001 Quality Management System * Strong technical writing and documentation skills
Quality Systems & Compliance Manager
Fort Lauderdale, FL ยท On-site
$90K - $120K/yr
Engineering Support * Compliance * Document Control * Continuous Improvement * Experience working within an ISO 9001 Quality Management System * Strong technical writing and documentation skills
... quality standards such as AS9100 or equivalent. * Drive full lifecycle systems engineering for ... embedded systems, from concept and architecture through detailed design, integration, verification ...
Quick apply
... quality standards such as AS9100 or equivalent. * Drive full lifecycle systems engineering for ... embedded systems, from concept and architecture through detailed design, integration, verification ...
Quality Systems & Compliance Manager
Fort Lauderdale, FL ยท On-site
$90K - $120K/yr
Engineering Support * Compliance * Document Control * Continuous Improvement * Experience working within an ISO 9001 Quality Management System * Strong technical writing and documentation skills
Quality Systems & Compliance Manager
Fort Lauderdale, FL ยท On-site
$90K - $120K/yr
Engineering Support * Compliance * Document Control * Continuous Improvement * Experience working within an ISO 9001 Quality Management System * Strong technical writing and documentation skills
Quality Systems Engineer information
See Florida salary details
$20.48 - $24.07
5% of jobs
$24.07 - $27.66
14% of jobs
$28.64 is the 25th percentile. Wages below this are outliers.
$27.66 - $31.26
23% of jobs
The median wage is $32.85 / hr.
$31.26 - $34.85
19% of jobs
$34.85 - $38.44
10% of jobs
$39.24 is the 75th percentile. Wages above this are outliers.
$38.44 - $42.04
19% of jobs
$42.04 - $45.63
7% of jobs
$45.63 - $49.22
1% of jobs
$49.22 - $52.81
0% of jobs
$52.81 - $56.41
0% of jobs
$56.41 - $60
2% of jobs
$20
$37
$59
How much do quality systems engineer jobs pay per hour?
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 is the difference between Quality Systems Engineer vs Quality Assurance Engineer?
| Aspect | Quality Systems Engineer | Quality Assurance Engineer |
|---|---|---|
| Certifications | ISO 9001, Six Sigma, ASQ certifications | ISO 9001, Six Sigma, ASQ certifications |
| Work Environment | Manufacturing, aerospace, automotive, medical devices | Manufacturing, software, healthcare, consumer products |
| Responsibilities | Developing and maintaining quality management systems, ensuring compliance, process improvement | Testing 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.
What are the key skills and qualifications needed to thrive as a quality systems engineer, and why are they important?
What is a quality systems engineer?
How does a quality systems engineer typically collaborate with cross-functional teams within an organization?

Full-time
Posted 4 days ago
Job description
Department: Quality
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Director Quality Management Systems
Description
The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company's Quality Management Systems, ensuring adherence to domestic and international regulations and company policies.
Key Responsibilities
- Quality Systems and Regulatory Compliance:
- Know and apply the Quality System and any appropriate Federal and International standards (FDA, ISO 13485, MDSAP, EU MDR, etc.)
- Provide leadership and strategy for the team in the overall administration and maintenance of the QMS processes, ensuring alignment with organizational goals.
- Ensure that Quality Management Systems documentation meets the required guidelines for maintaining FDA compliance and ISO/EC/MDR certification.
- Support the strategic initiatives of the company to achieve and maintain regulatory compliance.
- Corrective and Preventive Action:
- Oversees CAPA system, including maintenance, development and system validation.
- Develops and facilitates continuous training and development for the CAPA process, including root cause analysis and verification of effectiveness.
- Responsible for the reporting of CAPA system KPIs during Quality Systems Governance and Management Review.
- Operates as lead Subject Matter Expert during internal/external audits and inspections..
- Product/Process Nonconformance:
- Oversees NC system, including maintenance, development and system validation.
- Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and dispositions.
- Operates as lead Subject Matter Expert during internal/external audits and inspections.
- Product Corrections and Removals:
- Oversees the process for product event escalations, health hazard evaluation, and execution of product corrections and removals.
- Provides guidance and drives cross-functional collaboration to make timely decisions, based upon product risk.
- Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and final decisions.
- Operates as lead Subject Matter Expert during internal/external audits and inspections.
- Training and Cross-Functional Responsibilities:
- Oversees the Learning Management Solution (LMS), including maintenance, development and system validation.
- Develop training and competency solutions to meet the needs of the company and its Quality Management System.
- Monitors Quality Systems training curricula for completeness, appropriateness and execution.
- Responsible for the reporting of LMS system KPIs during Quality Systems Governance and Management Review.
- Operates as lead Subject Matter Expert during internal/external audits and inspections.
- Data Analytics & Reporting Responsibilities:
- Assist with the development of training materials and documentation to ensure effective dissemination of knowledge to team members and stakeholders.
- Responsible for compiling process data for presentation during Quality Systems Governance and Management Reviews.
- Facilitates Quality Systems Governance and Management Review meetings in accordance with company procedures.
Skills Knowledge and Expertise
Education:
- Bachelor's Degree in Engineering or related science from an accredited institution required; Master's Degree preferred.
Experience:
- Minimum of 6 years full-time medical device engineering/quality/regulatory technical experience. This experience shall be in addition to any college internships. Relevant experience in other areas may be considered.
- Experience in Change Management documentation systems preferred.
- Experience in electronic Quality Management Systems solutions (e.g. SmartSolve IQVIA, Cornerstone, Teamcenter).
- Experience in data management and reporting utilizing PowerBI.
- Professional Certification through the American Society for Quality (ASQ) or equivalent in Auditing for Medical Devices.
- Experience in software validation, operating within a Quality Management System
Functional/Technical Knowledge, Skills and Abilities Required:
- Demonstrated ability to lead cross-functional teams and project
- Demonstrated ability to communicate effectively quality related discussions
- Experience with the development, implementation, and maintenance of electronic solutions for Quality Management Systems elements such as: CAPA, Audits, Data Analysis, etc.
- Demonstrable knowledge of all domestic and international Quality System regulations.