Quality Engineer - Sr

Avanos Medical; Norcross (GA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Total Rewards

401(k) match

Onsite gym

Onsite cafeteria

Job summary

Avanos Medical is seeking a Sr Quality Engineer to lead post-market surveillance activities, assess product performance, and drive regulatory compliance across global markets. The role involves preparing PMSR/PSUR, performing investigations with root cause analysis, and coordinating recalls with Quality, Regulatory, and Clinical teams.

You will collaborate with Regulatory Affairs and cross-functional partners to ensure alignment with risk management and technical files, while tracking timelines

Qualifications

• BS in Engineering, Science or related field with 7+ years in medical devices QA/R&D.
• CQE or Six Sigma certification desirable.
• Experience with FDA QMSR, MDR, ISO 13485, MDSAP and regulatory submissions.

Responsibilities

• Prepare PMSR/PSUR per EU MDR and applicable regulations.
• Investigate complaints: RCA, risk assessment, reportability decisions.
• Coordinate recalls/field actions with cross-functional teams.
• Support audits from Notified Bodies, FDA, ISO.
• Maintain documentation in quality systems and risk files.

Skills

Regulatory knowledge

Technical writing

Cross-functional coordination

Root cause analysis

Problem solving

Leadership

Communication

Education

B.S. in Engineering

Tools

Minitab

SAP

EtQ

Six Sigma

Document Control software

Job description

Requisition ID: 7234 Job Title: Quality Engineer - Sr 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. The Role The Sr Quality Engineer is responsible for the ongoing monitoring, analysis, and reporting of product performance and safety data for medical devices/products once they are on the market. This role ensures compliance with applicable regulatory requirements (e.g., EU MDR, FDA 21 CFR Part 803/806/820, ISO 13485, MDSAP) by preparing Post-Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), performing complaint investigations, and supporting recall/field action management activities. The ideal candidate combines strong technical writing skills, regulatory knowledge, and cross-functional coordination ability to proactively identify product risks and drive corrective actions.
• Prepare, compile, and maintain Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) in accordance with EU MDR and other applicable regulations.
• Contribute to continuous improvement of PMS procedures, templates, and systems.
• Collaborate with Regulatory Affairs, Clinical, and Quality teams to ensure PMS documentation aligns with technical files and risk management documentation.
• Track PMS reporting timelines and ensure on-time submission per regulatory schedules (e.g., annual/biennial PSUR cycles based on device classification).
• Support internal and external audits (Notified Body, FDA, ISO) related to PMS, complaints, and vigilance processes.
• Prepare documentation and reports for Senior Management, Quality Assurance, and Regulatory Affairs and support each product platform with relevant post market quality data. Present GPMS related data to all levels of the organization.
• Conduct thorough investigations into product complaints, including root cause analysis (RCA), risk assessment, and determination of reportability (e.g., MDR/MDV, FDA MedWatch, Vigilance reporting).
• Document investigation findings, conclusions, and corrective actions in compliance with internal SOPs and regulatory requirements.
• Ensure timely closure of complaint files within defined KPIs/metrics.
• Support identification, evaluation, and execution of field corrective actions and recalls in accordance with company procedures and regulatory requirements (e.g., FDA 21 CFR Part 806, EU MDR Article 89).
• Prepare recall documentation, health hazard evaluations, and regulatory notifications.
• Supports the coordination of cross-functionally (Quality, Regulatory, Legal, Distribution, Customer Service) to ensure effective and timely execution of recalls/field actions.
• Track effectiveness checks and closure documentation for recall activities.
• Support inputs into Risk Management Files (ISO 14971) based on post-market data trends.
• Qualifications Required:
• A B.S. in Engineering, Science or related discipline. A minimum of seven (7) years of collective experience in Quality Assurance, R&D or related field in a medical device environment.
• Must be detail oriented, have excellent customer service, leadership and communication skills with co-workers and customers. Must be team-oriented with an ability to coach others. Must have excellent problem-solving skills, oral and written communication skills.
• CQE certification or Six Sigma Certification desirable.
• Experience with Microsoft Office Package. FDA QMSR, MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, ISO 13485, MDSAP, CMDR, Statistical Analysis Tools, Minitab, SAP, Document Control softwares such as EtQ or Agile, Six Sigma, Lean Manufacturing.
• 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.
• 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