Product Quality Specialist

Requisition ID:5509

Job Title:Product Quality Specialist

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.

The Avanos COVID-19 Vaccine Policy: This Policy applies to U.S. customer-facing / field-based employees & Avanos leadership: All U.S. customer-facing / field-based employees hires must be fully vaccinated against COVID-19. Proof of being fully vaccinated does not need to be disclosed until a job offer has been made but must be submitted within 48 hours after the acceptance of the job offer. If you have a qualifying medical condition or sincerely held religious belief or practice that precludes you from receiving a COVID-19 vaccine, you may apply for an exemption or deferral after you accept the job offer and before your scheduled start date. The reasonable accommodation provided to the employee, if any, will depend on the employee's job and the applicable facts, but it may include weekly COVID-19 testing and masking requirements. New hires who do not submit, before their scheduled start date, proof of being fully vaccinated or a request for a reasonable accommodation will have their job offer revoked.

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. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit .

Purpose / Summary

Utilize product technical knowledge, communication skills, and business expertise to provide internal and external customers with effective product quality and technical support for assigned product areas. To meet Sales, Quality, and Customer Care team requirements for product information and services, while strengthening Avanos's brand image and customer relationships. The Product Quality Specialist is viewed as the subject matter expert on the Avanos products and solutions that they support as well as being the technical leader in the EtQ complaint handling system.

Scope

The incumbent reports to the Post Market Surveillance Team Senior Manager. This position has considerable Regulatory Compliance impact in that it analyzes complaint and post-market surveillance information and links that information to appropriate Avanos organization components. This position also serves as a second and/or third-level source of technical and quality-related information to both internal and external customers.

Accountabilities / Expectations

• Ensure timely filing of product failure complaints into the computerized complaint handling system. Assessing all events for potential reportability status and escalating such events to the Health Authority Reporting Team as required.
• Continuously strive to be the best in providing quality product information about product attributes, material, and composition as well as usage to the healthcare customers both internal and external at a level requiring a nursing degree.
• Assist with the development of the team's annual business plans, objectives, and vision.
• Support the development and implementation of new products and solutions worldwide that meet and exceed customer requirements at required financial returns.
• Effectively manage a central repository of product and technical information ensuring accuracy and timeliness. Conduct periodic reviews of technical data and provide recommendations for on-site improvements.
• Provide ongoing product training to current and new members of the Customer Care Team, Administrative, Professional, Manufacturing, and Support Teams.
• Provide complaint handling system support for all team members as the established expert and go-to individual on the team.
• Provide recommendations for system enhancements and participate in all testing aspects of the complaint handling system.
• Record contact information, and support, and maintain accurate and complete records that meet internal requirements and satisfy local, domestic, and international regulatory and government requirements.
• Make recommendations for needed changes in process and procedure to ensure ongoing compliance with corporate, local, state, federal, and international requirements.
• Lead development and communication of policy and procedure documentation.
• Conduct trend analysis to identify future issues and or to dimension the risk/impact of current issues.
• Communicate details of complaint trend analysis and make recommendations to the appropriate levels within the Sector.
• Perform random audits to assess the quality of work performed in support of complaint handling and effectively communicate findings and suggestions for corrective and preventative actions (CAPA).
• Serve as a primary contact for key strategic customers experiencing ongoing product quality issues and concerns.

Key Relationships / Customer Expectations

Area Trade Market Managers, General Managers - Marketing Teams, HC Sales Team and functional team leaders, Quality and Regulatory, Customer Care, Distribution, direct end-user customers, and distributors.

• Interacting with internal and external customers and providing current and accurate product and technical information.
• Soliciting, organizing, and recording information on product problems and failures; conducting the appropriate trend analysis and making recommendations to address.
• Analyze complaint handling information and technical inquiries for trends and work within the leadership team to develop and implement a communication and training plan to address.
• Provide training to the Customer Care team to build talent within the department and enhance the overall customer experience.

The Product Quality Specialist (PQS) is responsible for ensuring that the entry of quality complaints is in accordance with established procedures and regulatory requirements. The Specialist will respond to customer (internal and external) inquiries regarding product information and technical documentation. The Specialist will be responsible for assisting in the development, communication, and training of responses from the Marketing, R&D, and Quality teams to both internal and external customers. The Specialist will have a working knowledge of the product, usage, market, and technical documentation for the products assigned.

Additionally, the PQS will function as an Alpharetta point person for complaint handling and technical support for Field Sales, Quality and Regulatory, Customer Care, and end-user customers. This function includes:

• Assuring that the Global sales team is connected to necessary information systems.
• Providing a main contact point to direct the International sales team to the appropriate resources/contact persons.
• Educating and facilitating learning on new products, sales tools, and collateral.

The PQS is the liaison between the Marketing, Research and Development, and Field Sales teams to ensure product information is communicated appropriately and accurately to the sales team and others with a need to know.

Key Leadership Behaviors

• Support achievement of total Avanos sales and operating profit objectives as established by Avanos sector management.
• Facilitate understanding and interpretation of key customer requirements for assigned responsibilities.
• Assist the Global Customer Care team and Quality with the development of long-range business planning and strategic vision.
• Demonstrate leadership and initiative to cause positive change that will result in overall improved effectiveness, quality, and productivity within the business.
• Actively seek and positively respond to performance and personal development feedback.
• Communicate fully with superiors, subordinates, and others who have a need to know.
• Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.
• Establish and maintain the required internal controls to assure compliance with Avanos requirements.

Qualifications

Required:

• Undergraduate degree
• 5 years of nursing or clinical experience
• Nursing certification/license
• Proficient in Microsoft Office applications
• Excellent communication skills (business writing, presentations, and interpersonal)
• Demonstrated success in a fast fast-paced, multi-tasking environment

Preferred:

• BSN
• Working knowledge of Medical Devices (Digestive Health, Respiratory Health, Acute and Chronic Pain devices)
• EtQ systems experience

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. If you are a current employee of Avanos, please .

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.

free onsite gym | benefits on day 1 | HQ region voted 'best place to live' by USA Today