Requisition ID: 7180
Job Title: Principal Quality Systems Engineer, QMS - Alpharetta, GA
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. For more information, visit www.avanos.com.
Essential Duties and Responsibilities:
The Principal Quality Systems Engineer – QMS serves as a senior subject matter expert and strategic contributor in the development, execution, and continuous improvement of critical Quality System processes. This position bridges high-level strategy with hands-on implementation, ensuring robust compliance, risk management, and operational efficiency across areas such as Quality System Strategic Planning (QSSP), Management Review, Corrective and Preventive Actions (CAPA), customer complaints handling, laboratory nonconformances and improvements, specification control, and sustainability-related change management. This position leads the QMS integration during mergers and acquisitions.
This individual leads cross-functional initiatives, drives quality system harmonization, and serves as the process owner /and process owner support of one or more core elements of the Quality Management System (QMS), contributing to regulatory inspection readiness and the advancement of quality culture throughout the organization.
Key Responsibilities:
- Serve as a business process owner or support and senior technical lead for key QMS elements (e.g., QSSP, Management Review, CAPA, customer complaints handling,health authorities reportability, recalls, change control, specification management, etc.).
- Lead and mentor teams in complex root cause investigations and development of effective corrective and preventive actions.
- Partner with stakeholders to drive quality improvements tied to customer complaints and product issues across the lifecycle.
- Develop and/or analyze quality metrics to monitor process health, effectiveness, and compliance.
- Collaborate with management to support audit readiness, regulatory inspections, and gap remediation activities.
- Ensure alignment of quality system elements with sustainability and product lifecycle strategies.
- Subject Matter / trainer for QMS and regulatory expectations.
- Evaluates new or revised documents of external origin applicable to the Quality Management System and supports the development of action plans to close identified gaps.
- Supports quality management in the review and approval of CAPAs, change orders, procedures, work instructions, customer complaints, health authorities reporting, recalls and any other applicable quality system documents.
- Leads the QMS integration during mergers and acquisitions.
- Supports and/or leads the quality organization in the implementation of project initiatives inclusive of QSSPs.
- Serves as a quality reviewer, approver and consultant for corporate laboratories in the areas of laboratory nonconformances, CAPA, procedures, test methods, validation and any other applicable document.
- Promotes continuous improvement within quality systems operations.
- Leads and/or represents the Quality Systems function in cross-site/global initiatives and system harmonization projects.
- Coaches junior engineers and support staff, sharing expertise and promoting professional growth.
Your qualifications
Required:
- Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
- 10-15 years of Quality Systems or Quality Engineering experience in a regulated industry (medical device, biotech, or pharma).
- Demonstrated leadership in owning and improving one or more QMS processes.
- Strong understanding of regulatory standards (FDA QSR, ISO 13485, EU MDR).
- Proven expertise in root cause analysis techniques and risk-based decision-making.
- Primarily office-based, 3 days minimum (Tuesday- Thursday) in the Alpharetta office, requiring prolonged periods of sitting, computer usage, and data review.
- Occasional lifting of materials weighing up to 25 lbs.
Preferred:
- Proficient in electronic QMS platforms (e.g., TrackWise, MasterControl, Veeva, ETQ).
- Effective communicator with the ability to influence cross-functional stakeholders and present to leadership.
- Project Management Professional (PMP) certification, or other certification from American Society of Quality (e.g., CQA, CQE, etc.).
- Experience leading quality improvement projects and regulatory audit activities.
- Hands-on experience with global or multi-site quality system harmonization efforts.
- 5-10% travel may be required to support global initiatives or attend/ provide training sessions.
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
