Quality Systems Engineer

Katalyst Healthcares and Life Sciences

Job Summary:
We are seeking a highly organized and detail-oriented Quality Systems Engineer to support quality-system activities within a regulated medical-device environment. The ideal candidate will have hands-on experience with CAPA, Nonconformance (NC) investigations, root-cause analysis, corrective actions, and quality-system documentation.
Roles & Responsibilities:

Manage and execute CAPA and Nonconformance (NC) investigation s in accordance with established procedures, quality-system requirements, and applicable medical-device regulations.
pply structured problem-solving and root-cause analysis methodologies to identify and address the underlying causes of quality issues.
Conduct risk-based assessments and ensure investigation conclusions are supported by objective evidence, sound rationale, and appropriate documentation.
Partner with investigation owners, process owners, subject-matter experts, and cross-functional stakeholders to collect evidence, resolve issues, and complete assigned actions.
Facilitate investigation follow-up meetings and document decisions, action items, risks, dependencies, and escalations.
Monitor and communicate investigation status, milestones, overdue actions, risks, and potential escalation requirements.
Ensure CAPA, NC, and investigation records are accurate, complete, clear, timely, traceable, and inspection-ready.
Track investigation milestones, action items, commitments, and due dates to support timely closure.
Enter, update, review, route, and maintain quality records within the applicable electronic Quality Management System (eQMS).
Support quality-system activities, documentation reviews, audits, and inspection-readiness initiatives.
Maintain effective follow-up and coordination across multiple investigations and quality-system deliverables.
Ensure activities are performed in compliance with company procedures, quality policies, and applicable regulatory requirements.
Identify recurring quality issues, trends, and opportunities for process improvement and communicate findings to relevant stakeholders.
Collaborate effectively with Quality, Manufacturing, Engineering, Operations, Regulatory, and other cross-functional teams.

Education & Experience:

Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
Preferred: Degree in Biomedical, Mechanical, Electrical, Chemical, Industrial Engineering, or a related field.
3+ years of experience in Quality Engineering, Quality Systems, Quality Assurance, or a related role within the medical-device industry.
Hands-on experience managing CAPA and Nonconformance (NC) investigations in a regulated environment.
Demonstrated experience leading investigations through the complete lifecycle, including containment, issue definition/bounding, data collection, root-cause analysis, corrections, corrective actions, and closure.

Apply

Vacancy posted 3 days ago

Similar jobs that could be interesting for youBased on the Quality Systems Engineer in Atlanta, GA vacancy

Quality Assurance Engineer
A Quality Engineer is an experienced-level position in the Development organization. As our in-house Quality Engineer, you will serve as a... ...applications, including ERP, EAM, CRM and Maximo. Understanding of system and network architecture, system platforms, system access,...
Suggested
Work at office
Work from home
Flexible hours
PowerPlan, Inc.
Atlanta, GA
3 days ago
Automation Test Engineer
Automation Test EngineerLocation: Cincinnati, OH // Atlanta, GA // Jacksonville, FLExp: 10+ yearsJob Description:5+ years knowledge of Automation Testing frameworks for APIs and UI and strong understanding of protocols, APIs (REST/SOAP), and web technologies.3+ years ...
Suggested
Contract work
United IT
Atlanta, GA
3 days ago
Software Test Engineer
...Job Profile for Software Test Engineer (USA)- Experience: 7+ Strong understanding of BSS... ...cause analysis and log analysis to find the system at fault Document and report test... ...methodologies to ensure high standards of quality Good hands-on experience with AI...
Suggested
Salesforce
Atlanta, GA
2 days ago
Software Quality Assurance Engineer
$90k - $115k
...Software Quality Assurance Engineer $90,000-$115,000 Base Salary. Position eligible for additional incentives including bonus, 401(k) match, health... ...to-end test coverage. • Strong experience in functional, system integration, and end-to-end testing. • Strong written and...
Suggested
Full time
Casual work
Remote work
FairSquare Inc.
Atlanta, GA
4 days ago
Senior Software Quality Assurance Engineer
...Senior Software Quality Assurance Engineer Company: Swisslog Logistics Inc. Location: Atlanta, US Additional posting countries (for remote jobs... ...on applications Participate in requirements gathering, system analysis Review software design documentation and low-level...
Suggested
Work experience placement
Local area
Remote work
Worldwide
KUKA AG
Atlanta, GA
2 days ago
Mission Critical QA/QC Engineer / Manager
$190k - $230k
...Rinvio is hiring a Mission Critical QA/QC Engineer / Manager for quality management for data center and mission-critical MEP construction in the Atlanta, GA market. Pay: $190,000-$230,000/year, based on experience Location: Atlanta, GA Schedule: Full-time mission...
Weekly pay
Full time
For subcontractor
Rinvio
Atlanta, GA
2 days ago
Quality Engineer I
$21 - $22 per hour
...Job Title: Quality Engineer IJob Description The Quality Engineer I supports manufacturing operations by ensuring that products and processes... ...quality issues, maintain compliance with the Quality System, and drive continuous improvement. Responsibilities Provide...
Full time
Contract work
Temporary work
Internship
Actalent
Atlanta, GA
4 days ago
Quality Engineer
...automation and controls, audiovisual, and IT systems. Headquarters in Tysons, Virginia, M.C.... ...power and technology solutions through engineering expertise and smart systems integration.... ...industries. ResponsibilitiesThe Quality Engineer 2 is responsible for following...
For subcontractor
M.C. Dean, Inc.
Atlanta, GA
5 days ago
QA Test Engineer - Remote
...Job Description Job Description QA Engineer Role Type: Contractor Location: Remote About the Role We are looking for experienced... ...evaluate technical outputs, identify issues, and maintain high-quality standards. Key Responsibilities Design and execute...
Remote job
For contractors
YO AI Labs
Atlanta, GA
17 days ago
QUALITY ENGINEER 3
...Quality Engineer 3Department: Quality Division: OperationsAt Daniel Defense, Only the Best Build the Best…Daniel Defense engineers and manufactures the world’s finest weapon systems and accessories. Our mission of Honor God. Defend Freedom is accomplished by serving customers...
Contract work
Temporary work
Daniel Defense
Atlanta, GA
2 days ago
Quality Engineer
$25 - $32 per hour
...Quality Engineer I Pay Range: $25/hr to $32/hr Location: Atlanta, GA 30313 Work Type: Onsite Contract Duration: 12 Months, Possible... ...activities comply with applicable procedures, Quality System requirements, and regulatory standards. Required Qualifications...
Contract work
Temporary work
Internship
Medical Devices and Supplies
Atlanta, GA
4 days ago
Quality Engineer II
...Overview Reporting to the Corporate Quality Engineer Center of Excellence Manager, the Quality Engineer II provides quality engineering... ...modifications, and capital projects to ensure robust quality system implementation and successful launch. Participate in -...
Work at office
The Marzetti Company
Atlanta, GA
5 days ago
Senior Quality Engineer
$80k - $100k
...Position Job Type: Permanent Title: Senior Quality Engineer Location: Atlanta, GA Build a brilliant future with Hiscox Hybrid role with an expectation of being in the office 2–3 days per week We’re on the lookout for a dynamic and passionate Software Quality Engineer...
Permanent employment
Temporary work
Work at office
Immediate start
Shift work
2 days per week
3 days per week
HINCX Hiscox Inc.
Atlanta, GA
2 days ago
Senior Supplier Quality Engineer
...hardware iteration, we deliver high-speed systems at the pace of the modern battlefield.... ...asymmetric advantage. About The Role: The Quality & Reliability Team at Hermeus are truly... ...provide crucial design feedback to our engineering team and can rapidly iterate with design...
Weekly pay
Permanent employment
Work at office
Hermeus
Atlanta, GA
5 days ago
Sr. Supplier Quality Engineer
...Supplier Quality Engineer Join Hitachi Energy and play a key role in delivering high-quality, reliable products that power communities... ...in FMEA, SPC, or root cause analysis ~ Knowledge of quality systems, standards, and continuous improvement methodologies ~ Effective...
Hitachi
Atlanta, GA
1 day ago
QA ENGINEER
...OpenKyber Inc is seeking a detail-oriented QA Analyst Healthcare (2-3 years experience) to ensure the quality, accuracy, and reliability of healthcare applications and data systems. This role supports testing activities in a regulated healthcare environment. Key...
Remote work
Openkyber
Atlanta, GA
2 days ago
Quality Engineer - Infotainment & Connect
$88.9k - $110k
...Position Overview The Quality Engineer - Infotainment & Connect, within the Complete Vehicle department at Porsche Engineering, is responsible... ...topics affecting in-vehicle infotainment and connectivity systems. As the technical expert, the position acts as a key...
Temporary work
Work experience placement
Work at office
Long distance
Shift work
Dr. Ing. h.c. F. Porsche AG
Atlanta, GA
a month ago
AI QA and Test Engineer
...SGA), is searching for an AI QA and Test Engineer for a contract assignment with one of... ...workflows. This role focuses on prompt/agent quality assurance, evaluation framework... ...with hands-on experience testing LLM-based systems, designing evaluation criteria, and using...
Contract work
Remote work
Software Guidance & Assistance
Atlanta, GA
1 day ago
QA Engineer III
...Job Description Job Description Position: QA Engineer III Location: Atlanta, GA Duration: 5 Months Client: Southern Company... ...Services is seeking an experienced QA Engineer III to support quality engineering, test automation, performance testing, and release...
4P Consulting Inc.
Atlanta, GA
2 days ago
Quality Assurance Engineer- Digital Experience, MarTech & Loyalty
...Job Description Job Description Job Title: QA Engineer – Digital Ordering & Customer Experience Location: Atlanta, GA Role Overview: You will ensure high-grade quality across our client’s consumer-facing digital ordering channels, ( iOS & Android apps)....
Pointwest Technologies Corp
Atlanta, GA
4 days ago
Quality Engineer III (Remote NC, TX, AZ, GA)
...testing of software, patches, and upgrades to system products. Resolves complex problems and failures... ...deliverables, test automation acceptance, and quality gates for enterprise applications. Champion quality engineer principles, including shift-left mindset, test...
Remote work
Shift work
First Citizens Bank
Atlanta, GA
4 days ago
Quality Engineering Intern
$18 - $20 per hour
...Quality Engineering Intern PEUS Quality Engineers are responsible for identifying, assessing and managing root cause/corrective actions... ...Quality Engineers, tasks involve working across all vehicle systems engineering disciplines to maintain continuous quality improvement...
Hourly pay
Full time
Internship
Local area
Porsche
Atlanta, GA
4 days ago
Senior QA Automation Engineer
...Senior Automated Quality EngineeringHands-on senior individual contributor responsible... ...building and scaling automated quality engineering across Customer and Commercial product teams... ...working in product teams; enterprise systems experience preferred (e.g., supply chain...
InterSources
Atlanta, GA
3 days ago
Senior QA Automation Engineer
...privacy-first architecture, modern shared-code strategy, and the engineering rigor needed to grow sustainably.We build for audiences who... ...and for advertisers who depend on us to deliver reliable, high-quality monetization. The work is tangible: every improvement we make...
Contract work
Local area
Remote work
Weather Group Television LLC
Atlanta, GA
1 day ago
QA Automation Engineer
...Automation EngineerAtlanta, Georgia, United StatesRole DescriptionQuality Engineering is transforming into a Cloud-based DevOps oriented Automation centric organization. In order to deliver high-quality software with speed to market in mind, we are looking for an...
The Hive Careers Ltd
Atlanta, GA
3 days ago
QA Automation Engineer
Job TitleProven experience conducting end-to-end testing across multiple eCommerce web applications.Strong proficiency in SQL, including the ability to write complex joins across multiple tables to retrieve and validate data for automation testing.Hands-on experience with...
Cedent Life Talent
Atlanta, GA
4 days ago
QA Automation Engineer
...We are seeking a highly skilled Senior SDET (Software Development Engineer in Test) with strong expertise in test automation, quality engineering, and AI-enabled testing solutions. The ideal candidate will have extensive experience in designing and implementing automation...
Prophecy Technologies
Atlanta, GA
4 days ago
Quality System engineer
...Job Description Job Description Job Description: We are seeking a Quality Systems Engineer to support and maintain the Quality Management System (QMS) in a regulated manufacturing environment. The ideal candidate will ensure compliance with applicable regulatory...
Work at office
Katalyst Healthcares & Life Sciences
Atlanta, GA
4 days ago
Principal Quality Engineer
$115k - $130k
...Principal Quality Engineer Build a brilliant future with Hiscox Location: Atlanta, GA We are seeking an innovative Principal Quality Engineer who will advance our testing capabilities through modern automation and AI-driven methodologies. This position is responsible...
Temporary work
Work at office
Shift work
Hiscox USA
Atlanta, GA
3 days ago
Quality Engineer (AI Testing)
$79.6k - $176.3k
Quality Engineer (AI Testing) Position Description We are seeking a Quality Engineer to support AI related testing efforts for our team... ...• Testing experience, 5, Expert • AI/ML or data driven system testing, 3, Very Good • Agile experience, 5, Very Good •...
Contract work
Local area
Atlanta, GA
15 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Quality Systems Engineer. Be the first to apply!