Quality Engineer - Sr

Avanos Medical, Inc.; Northern (KY); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

401(k) match

Onsite gym

Onsite cafeteria

Total Rewards package

Job summary

Avanos Medical, Inc. in the United States is seeking a Senior Quality Engineer to monitor, analyze, and report product performance and safety data for medical devices on the market.

You will ensure compliance with EU MDR, FDA regulations, ISO 13485, and MDSAP by preparing PMSR and PSUR, performing investigations, and supporting recalls and field actions across cross-functional teams.

Qualifications

• A BS in Engineering, Science or related discipline is required.
• Minimum seven years of QA/R&D or related medical device experience.

Responsibilities

• Prepare, compile, and maintain PMSR and PSUR reports per EU MDR and other regulations.
• Contribute to continuous improvement of PMS procedures, templates, and systems.
• Collaborate with Regulatory Affairs, Clinical, and Quality teams to align with technical files and risk management.
• Track PMS timelines and ensure on-time submissions per regulatory schedules.
• Support internal and external audits (Notified Body, FDA, ISO) related to PMS and vigilance.
• Prepare documentation and reports for Senior Management and Regulatory Affairs; present GPMS data.
• Conduct root-cause analysis, risk assessment, and determine reportability (MDR/MDV, FDA MedWatch).
• Document findings and corrective actions in line with SOPs and regs.
• Ensure timely closure of complaint files within KPIs.
• Support recalls/field actions and regulatory notifications per FDA/EU rules.
• Coordinate cross-functionally to execute recalls efficiently.
• Track effectiveness checks and closure for recall actions.
• Input into ISO 14971 Risk Management Files based on post-market data trends.

Skills

Detail oriented

Leadership

Communication

Teamwork

Problem solving

Oral communication

Written communication

Education

Bachelor's degree in Engineering, Science or related discipline

Tools

Microsoft Office

EtQ

SAP

Minitab

Six Sigma

Lean Manufacturing

Document Control software (EtQ/Agile)

Job description

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.

Responsibilities

• 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.

Preferred:

• 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.

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