Top 49 Sr Systems Engineer Jobs in Suwanee, GA

Senior Quality Systems Engineer
Avanos Medical —Alpharetta, GA
- Full-time
- Management
- Engineering
- Master's degree
- Health insurance
- 401(k) matching
Senior Control Systems Engineer
Thermo Systems LLC —Georgia
- $120,000 - $170,000 a year
- Full-time
- Bachelor of Science
- Travel
- US work authorization
- Travel reimbursement
- Relocation assistance
Quick Apply
Senior Systems Engineer I
LexisNexis Risk Solutions —Alpharetta, GA
- $78,800 - $131,300 a year
- Full-time
- 5 years
- Windows
- Continuous improvement
- Disability insurance
- Health insurance
Senior Systems Engineer I
RELX —Alpharetta, GA
- $78,800 - $131,300 a year
- Full-time
- 5 years
- Windows
- Continuous improvement
- Disability insurance
- Health insurance
Senior Business Systems Analyst
Siemens Healthineers —Atlanta, GA
- $149,603.75 a year
- Full-time
- 5 years
- Engineering
- Office
SENIOR SOFTWARE ENGINEER
Synopsis Technologies —Alpharetta, GA
- Computer Science
- Research
- Travel
Senior SharePoint Engineer
Georgia System Operations Corporation —Tucker, GA
- $117,600 - $147,000 a year
- Full-time
- Hybrid work
- Azure
- 6 years
- Computer Science
- Health insurance
- Dental insurance
Quick Apply
Senior System Engineer
Colonial Pipeline Company —Alpharetta, GA
- Full-time
- Computer Science
- 5 years
- System design
- Retirement plan
1713 - Senior Systems Engineer
Sigma Defense —Duluth, GA
- $80,000 - $100,000 a year
- Full-time
- Computer Science
- Bachelor of Science
- System design
- Health savings account
- AD&D insurance
Quick Apply
Sr. Engineer, Business Systems - DC Applications
Petco —Braselton, GA
- Full-time
- Computer science
- Computer Science
- 5 years
- Health insurance
- 401(k)
11d
Sr Systems Engineer
Primetals Technologies USA LLC —Alpharetta, GA
- 5 years
- Bachelor of Science
- Pass drug screening
- Health savings account
- Dental insurance
Senior Systems Software Engineer (Backend Engineer) - School of Nursing
Emory University —Atlanta, GA
- Full-time
- Hybrid work
- Computer science
- Computer Science
- System design
- Work from home
Sr. Systems Engineer-IBM i, AIX, Storage, and Backup
CloudFirst —Marietta, GA
- $100,000 - $125,000 a year
- Remote
- Computer Science
- System design
- SQL
Quick Apply
6d
Senior Systems Engineer
Verifone —Alpharetta, GA
- On call
- DevOps
- Mentoring
- Senior level
Quick Apply
6d
Sr. System Safety Engineer
Viasat, Inc. —Duluth, GA
- $141,500 - $264,000 a year
- Online Application
- Schematics
- Office
- Analysis skills
Sr Systems Engineer
Primetals Technologies —Alpharetta, GA
- 5 years
- Bachelor of Science
- Pass drug screening
- Health savings account
- Dental insurance
Senior Engineer, Systems Engineering
Intercontinental Exchange Holdings, Inc. —Atlanta, GA
- Full-time
- 5 years
- Engineering
- System design
Sr Principal Business Systems Analyst
UKG (Ultimate Kronos Group) —Alpharetta, GA
- Hybrid work
- 5 years
- Office
- Master's degree
13d
Senior SCADA Engineer
Colonial Pipeline Company —Alpharetta, GA
- Full-time
- Computer Science
- Engineering
- System design
- Retirement plan
Senior Systems Engineer
Euronet Worldwide, Inc. —Norcross, GA
- Full-time
- Computer Science
- 5 years
- System design
- Employee stock purchase plan
- Paid holidays
Quick Apply
1d

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Senior Quality Systems Engineer

Avanos Medical -
Alpharetta, GA

Apply Now

Job Details

Full-time

Benefits

Health insurance
On-site gym
401(k) matching
Benefits from day one

Qualifications

Quality management standards in production
Defect resolution root cause analysis
ISO standards
Corrective and preventive actions (CAPA)
Quality risk management
Quality control data analysis
Data interpretation
Regulatory readiness in healthcare
Biomedical regulatory compliance
FDA regulations

Full Job Description

Requisition ID: 7063

Job Title: Senior Quality Systems Engineer

Job Country: United States (US)

Here at Avanos Medical, we passionately believe in three things:

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com.

Essential Duties and Responsibilities:

The Senior Quality Systems Engineer – CAPA & Compliance is responsible for leading and maintaining the effectiveness of the Corrective and Preventive Action (CAPA) system and ensuring ongoing compliance with applicable global regulatory requirements and quality standards. This role plays a critical part in driving continuous improvement, ensuring robust root cause analysis, and maintaining audit readiness across the organization.

Key Responsibilities:

CAPA Management

Act as a subject matter expert (SME) for CAPA, non-conforming product, deviations (quality non-conformance) and compliance-related activities.
Lead the end-to-end CAPA, non-conforming product and deviations (quality non-conformance) processes, including initiation, investigation, root cause analysis, action planning, implementation, and effectiveness verification.
Ensure CAPA activities are compliant with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
Review and approve CAPA records to ensure completeness, accuracy, and timeliness. Coordinates CAPA Review Board, publish meeting minutes and ensures actions are completed on a timely manner.
Monitor CAPA metrics and quality data sources trends to identify systemic issues and drive continuous improvement. Owns and/or supports the quality data trending process.
Facilitate cross-functional CAPA review meetings and provide guidance on investigation techniques and problem-solving methodologies. Facilitates CAPA and lead-instructor / in-person QMS compliance training
Implement and promote best practices in root cause analysis (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
Analyze quality data and trends to proactively identify risks and opportunities.

Compliance & Quality Systems

Drive improvements in quality system processes, particularly CAPA effectiveness and timeliness.
Maintain compliance with global regulatory requirements and internal quality management system (QMS) procedures.
Support internal and external audits, including FDA inspections, notified body audits, and customer audits.
Lead or support responses to audit findings, including CAPA development and implementation.
Ensure inspection readiness and support regulatory submissions as needed.

Your qualifications

Required:

Bachelor’s degree in engineering, Life Sciences, or a related technical field required.
Minimum of 5 years of experience in quality systems within the medical device or regulated industry.
Strong experience managing CAPA systems and regulatory compliance activities.
Strong data analysis and trending skills, with the ability to interpret complex quality data, identify patterns, and drive data-driven decision-making.
Comprehensive knowledge of FDA QSR, ISO 13485, EU MDR, and related quality system regulations and standards.
Strong understanding of root cause analysis tools and risk management principles.
Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.

Preferred:

Master’s degree preferred.
7+ years of experience in quality systems, quality engineering, or regulatory compliance within a regulated industry (medical device, pharmaceutical, etc.).
2+ years of leadership or management experience in a quality systems role.
Demonstrated success in leading quality system audits, managing CAPAs, and resolving complex quality issues.
Exceptional leadership, interpersonal, and communication skills with the ability to influence at all levels of the organization.
Proficient in eQMS platforms (e.g., TrackWise, MasterControl, ETQ) and Microsoft Office Suite.
Lean Six Sigma certification (Green Belt or higher).

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, please apply here.

Join us at Avanos
Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

Make your career count
Our commitment to improving the health and wellbeing of others begins with our employees – through a comprehensive and competitive range of benefits. We provide more than just a salary – our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.

Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.

Avanos also offers the following:

benefits on day 1

free onsite gym

onsite cafeteria

HQ region voted 'best place to live' by USA Today

uncapped sales commissions

Apply Now

Refine Your Search

Sr Systems Engineer jobs in Suwanee, GA

Senior Quality Systems Engineer

Senior Control Systems Engineer

Senior Systems Engineer I

Senior Systems Engineer I

Senior Business Systems Analyst

SENIOR SOFTWARE ENGINEER

Senior SharePoint Engineer

Senior System Engineer

1713 - Senior Systems Engineer

Sr. Engineer, Business Systems - DC Applications

Sr Systems Engineer

Senior Systems Software Engineer (Backend Engineer) - School of Nursing

Sr. Systems Engineer-IBM i, AIX, Storage, and Backup

Senior Systems Engineer

Sr. System Safety Engineer

Sr Systems Engineer

Senior Engineer, Systems Engineering

Sr Principal Business Systems Analyst

Senior SCADA Engineer

Senior Systems Engineer

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