Technical Leader GPMS

Requisition ID:6533

Job Title:Technical Leader GPMS

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

The Role

The Technical Quality Leader I (Sustaining) position is to lead the on-going activities required to support the assigned product category activities.

These activities include, but are not limited to:

• Leading the the quality engineering activities required to support commercialized medical devices within respective franchises.
• Collaborating with R&D and Supply Chain on product opportunities post-commercialization, monitoring and analyzing complaint data, leading root cause corrective actions and proactively supporting business strategies.
• Supporting design changes, product enhancements, material changes, and process changes; investigation of product non-conformances; communication with customers, ensure compliance to quality system requirements; support Avanos operated manufacturing facilities and supply base.
• Solving challenging technical problems, providing expertise in related specific field of knowledge and consulting on complex opportunities
  
  
  
  • Utilizing Root Cause Analysis concepts to investigate opportunities and implement Corrective and Preventive Actions including effectiveness checks
  
  
  
  
• Assist with Customer communications by showing expertise in the product manufacturing, composition and clinical use to represent the company
• Communicate accomplishments, abnormal events, and challenges effectively throughout all levels of the organization
• Lead Sustaining projects and action items to completion,
• Lead the implementation of quality concepts that drive future growth and support business strategies,
• Coach and Mentor team members to increase their technical understanding of a product, process, or concept, and
• Review project details, support new and emerging concepts,

Qualifications

Required

• B.S. in Engineering, Science or related field
• Minimum of 5 years of collective experience in product development, manufacturing and/or quality within a medical device environment
• Strong understanding of medical device Risk Management (ISO 14971)
• Effective working knowledge of domestic and international medical device regulations including 21CFR 820 and ISO 13485
• Strong analytical, problem solving, and technical writing skills
• Performing product testing using statistical concepts to obtain results and communicating data analysis summaries to all levels of the organization.
• Proficient with Microsoft Office programs
• Validation execution along with writing, reviewing, and approving Protocols and Reports

Preferred

• Graduate Degree
• Minimum of 7 years of collective experience in product development, manufacturing and/or quality within a medical device environment
• Experience with EU MDR 2017/745, CMDCAS, SFDA, JPAL MHLW, ANVISA MEDDEV.2.7/1, ISO 60601, ISO 10993 and other regulations/agencies.
• Lean Six Sigma Black Belt
• Quality Regulatory Certification eg CQE, CRE, CQM/OE, RAC
• Experience with MDSAP audits
• Working fluency in Spanish
• Successfully leads technical and project teams to solve complex problems, make decisions with cross functional engagement and driving consensus
• Clearly and succintly communicates critical information with internal and external customers/ stakeholders assuring accountability
• Successful track record of resolving complex technical issues and implementing clinically appropriate solutions.
• Influence and Support decision making of cross functional leaders and Senior Management
• Mentors engineers, business partners, and/ or quality professionals in best practices, industry trends, engineering, validations, quality systems, auditing & communcation skills
• Assessing product designs and improving process related challenges with proven successes.
• Advanced Excel user comfortable creating pivot tables
• Data Analysis Skills (Statistical Analysis)
• Use of Statistical Software (Minitab, JMP, SPC, etc)
• Project Management understanding

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

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
• uncapped sales commissions