Principal Quality Systems Engineer, QMS

Avanos Medical; Alpharetta (GA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Onsite gym

Onsite cafeteria

401(k) with immediate vesting

Day-one health benefits

Job summary

Avanos Medical, a Georgia-based medical device company, seeks a senior Quality Systems leader to own core QMS processes and drive CAPA investigations. You will partner with cross-functional teams to improve product quality across the lifecycle and support regulatory inspections.

The role emphasizes deep regulatory expertise (FDA QSR, ISO 13485, EU MDR), root-cause analysis, and global QMS harmonization, with three days per week in Alpharetta and up to 10% travel.

Qualifications

• Bachelor's degree in engineering, life sciences, or related technical field.
• 10–15 years of quality systems or quality engineering in a regulated environment (medical devices, biotech, pharma).
• Demonstrated leadership in owning and improving one or more QMS processes.
• Strong grasp of FDA QSR, ISO 13485, and EU MDR.
• Proven expertise in root cause analysis and risk-based decision-making.
• Proficiency with TrackWise, MasterControl, Veeva, or ETQ.
• PMP or ASQ credentials (CQA, CQE) preferred.
• Experience leading quality improvement initiatives and regulatory audits.
• Experience with global/multi-site QMS harmonization.
• Office-based role with 3+ days/week in Alpharetta; travel 5–10%.

Responsibilities

• Serve as senior process owner for core QMS elements (QSSP, Management Review, CAPA, complaints, health authority reportability, recalls, change control, specifications).
• Lead complex root cause investigations and develop effective CAPAs.
• Collaborate with stakeholders to improve quality outcomes across product lifecycle.
• Develop and analyze quality metrics to track performance and compliance.
• Maintain audit readiness and support regulatory inspections; close gaps.
• Align quality processes with sustainability goals and product lifecycle strategies.
• Act as SME and trainer for QMS and regulatory expectations.
• Review external-origin documents and address gaps with action plans.
• Review and approve CAPAs, change orders, procedures, and validation documents.
• Lead QMS integration during mergers/acquisitions; support strategic plans.
• Provide guidance to laboratories on nonconformances and methods.
• Drive continuous improvement across quality systems and cross-site harmonization.
• Coach junior engineers and support staff.

Skills

Leadership

Cross-functional influence

Communication

Regulatory awareness

Quality metrics analysis

Education

Bachelor's degree in engineering or life sciences

Tools

TrackWise

MasterControl

Veeva

ETQ

Job description

Requirements

Must have:

• – We require a bachelors degree in engineering, life sciences, or a related technical field.
• – We look for 10–15 years of quality systems or quality engineering experience in a regulated environment such as medical devices, biotech, or pharma.
• – We need demonstrated leadership in owning and improving one or more QMS processes.
• – We expect a strong grasp of regulatory frameworks including FDA QSR, ISO 13485, and EU MDR.
• – We value proven expertise in root cause analysis methods and risk-based decision-making.
• – We need proficiency in electronic QMS platforms such as TrackWise, MasterControl, Veeva, or ETQ.
• – We prefer effective communication skills with the ability to influence cross-functional partners and present to leadership.
• – We value PMP certification or other ASQ credentials such as CQA or CQE.
• – We prefer experience leading quality improvement initiatives and regulatory audit activities.
• – We value hands‑on experience with global or multi‑site quality system harmonization efforts.
• – This role is primarily office-based, with a minimum of three days per week in our Alpharetta office, and requires prolonged sitting, computer work, and data review.
• – The role may involve occasional lifting of materials up to 25 lbs.
• – The position may require 5–10% travel to support global initiatives or deliver training sessions.

Responsibilities:

• We serve as a senior process owner or support lead for core QMS elements such as QSSP, Management Review, CAPA, customer complaints, health authority reportability, recalls, change control, and specification management.
• We lead and coach teams through complex root cause investigations and the development of effective corrective and preventive actions.
• We partner with stakeholders to improve quality outcomes related to customer complaints and product issues across the product lifecycle.
• We develop and analyze quality metrics to track process performance, effectiveness, and compliance.
• We collaborate with management to maintain audit readiness, support regulatory inspections, and close identified gaps.
• We ensure quality system processes align with sustainability goals and product lifecycle strategies.
• We act as a subject matter expert and trainer for QMS and regulatory expectations.
• We review external-origin documents relevant to the QMS and help create action plans to address any gaps.
• We support the review and approval of CAPAs, change orders, procedures, work instructions, customer complaints, health authority reporting, recalls, and other quality documents.
• We lead QMS integration efforts during mergers and acquisitions.
• We support or lead project initiatives, including quality system strategic plans.
• We review, approve, and advise corporate laboratories on laboratory nonconformances, CAPA, procedures, test methods, validation, and related documents.
• We drive continuous improvement across quality systems operations.
• We lead or represent the Quality Systems function in cross-site and global harmonization projects.
• We coach junior engineers and support staff to build expertise and professional growth.

Company:

We are Avanos Medical, a medical device company headquartered in Alpharetta, Georgia, focused on delivering clinically superior breakthrough solutions that help patients return to what matters most. We operate in more than 90 countries and are committed to innovation, quality, and improving healthcare outcomes, including reducing opioid use and supporting patients from surgery through recovery. We offer a comprehensive Total Rewards package that includes pay, health care, retirement, and work/life benefits, plus a 401(k) match with immediate vesting. Our benefits also include coverage starting on day one, a free onsite gym, an onsite cafeteria, and a headquarters region recognized as a top place to live.