Principal Quality Systems Engineer, QMS - Alpharetta, GA

Principal Quality Systems Engineer, QMS - Alpharetta, GA

United States (US)

• 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 expert and trainer for QMS and regulatory expectations.
• Evaluate new or revised documents of external origin applicable to the Quality Management System and support the development of action plans to close identified gaps.
• Support 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.
• Lead the QMS integration during mergers and acquisitions.
• Support and/or lead the quality organization in the implementation of project initiatives inclusive of QSSPs.
• Serve 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.
• Promote continuous improvement within quality systems operations.
• Lead and/or represent the Quality Systems function in cross-site/global initiatives and system harmonization projects.
• Coach junior engineers and support staff, sharing expertise and promoting professional growth.

• 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.

• Proficient in electronic QMS platforms (e.g., Track Wise, Master Control, 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.

• Avanos offers a generous 401(k) employer match of 100% of each pretax dollar contributed on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.
• Benefits on day 1: free onsite gym, onsite cafeteria.
• HQ region voted "best place to live" by USA Today.
• Uncapped sales commissions.