Senior Director, Global Quality Operations - Alpharetta, United States - Avanos Medical

Description

Requisition ID:5559

Job Title:Senior Director, Global Quality Operations

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

Job Position Purpose / Summary

The Sr Director, Global Quality Operations is part of the Global Quality organization and reports directly to theSr. Vice President, Global Quality. This position is accountable for providing leadership and direction in the implementation of prevention-based programs and processes to ensure the manufacture and enhancement of safe and effective medical devices. This position has all global manufacturing plant Quality Assurance organizations reporting in directly to it and, consequently, has a strong regulatory compliance component applied to the manufacture of all Avanos products. This position is also responsible for quality within the Avanos global distribution network. This position works collaboratively with Franchise leadership, Research & Development, Regulatory Affairs, Product Supply and Marketing teams to ensure that the customer needs for safe and effective products are met. Corporate Sustaining Engineering teams and Sterilization Sciences team also report to this position.

Job Position Scope

The Senior Director of Global Quality Operations reports to the Senior Vice President of Global Quality. Thisposition has considerable global responsibility including direct reporting of QA organizations in all manufacturing facilities, Distribution Quality Sustaining Engineering teams and Sterilization Sciences team.

Incumbent is responsible for maintaining and enhancing existing QA functional systems in a manner thateffectively supports the growth of the business. To that end, a key responsibility of this position is to have anunderstanding of the business needs and product supply's strategic plan. The incumbent provides a linkbetween staff QA and the QA teams at remote manufacturing sites, suppliers, contract service providers, andother vendors.

A second important aspect of this position is understanding complex manufacturing processes and the qualityprocesses, systems, and tools used to measure and control them. Such understanding will help in the development and implementation of statistical control and evaluation methods and application of other qualitytools to support process control and improvement.

A third important responsibility includes acquisition, analysis, and reporting of all product information and data related to product integrity, stability, and efficacy; the investigation of complaints and responses to the customer; develop, implement and manage processes for monitoring of failure, failure investigation, and field service issues of the entire product line, including hardware.

An additional critical responsibility is ensuring compliance within our global distribution network. Ensuring products are stored, segregated, and handled properly to drive compliance with our 3PLs around the globe. Responsible for maintaining communication between the various warehouse management systems and SAP, specifically with products on hold.

Job Position Accountabilities / Expectations

1. Provide Quality functional leadership and expertise to global organization such that it contributes to the development, manufacture, and distribution of safe and effective products.
2. Provide mentoring and coaching to the Quality Manager Leadership at the Manufacturing sites and the Corporate Sustaining Engineering teams and Sterilization Sciences team.
3. Assure Quality Operations complies with Domestic and International regulatory requirements.
4. Develop programs and procedures that will provide leadership and direction in assuring successful implementation of staff QA functional systems, and help enhance manufacturing plant prevention-based quality awareness.
5. Establish and maintain a strong failure investigation resolution system utilizing the Product Surveillance process. Interact directly with product supply, marketing, R&D, and other departments, as required with respect to product failure reporting and investigation.
6. Manage the regional and plant-based Quality teams and implement continuous quality improvement programs.
7. Manage all aspects of plant-based quality including cost reduction, process reliability, problem resolution, complaint investigation, product release, document control, and CAPA.
8. Directs CAPA activities and maintains the CAPA system. Including initiation, support of the root cause investigation, closure, and verification of effectiveness. Ensures compliance to applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, Medical Device Directive, ISO, etc.).
9. Establish and maintain a strong complaint resolution system through the Product Surveillance process. Interact directly with product supply, marketing,and regulatory affairs as required with respect to product failure reporting and investigation.
10. Provide for training in technical, managerial, and administrative skills in order to meet the development needs of team members.


11. Serve as a liaison internally with legal as well as externally with FDA, international health ministries, and consulting organizations.


12. Provide functional direction to the Quality teams by implementing and maintaining quality policies, instructions, and control procedures.


13. Provide leadership to ensure the organization attracts, develops and retains the best talent management.

Key Relationships / Customer Expectations

Key customers:

Sales & Marketing, Global Regulatory Affairs, Global Product Safety, Global Quality Assurance,Global Product Supply, other Quality Assurance Team Members, Legal, M&A, and Research and Development.

Expectations:

1. Leadership in Manufacturing site Quality Management and productivity improvement;
2. Implement and maintain Product quality and process control procedures at the plant level;
3. Ensure processes meet requirement of ISO and QSR;
4. Monitoring QSR compliance in remote manufacturing locations;
5. Leadership in Problem solving and problem resolution as well as complaint and product failure investigations and resolution.
6. Provide leadership with Quality Platform Leaders in problem solving and problem resolution as well as complaint and product failure investigations.

Qualifications

Required:

• Minimum of Four (4) year degree in Science / Engineering degree
• 15+ years related leadership/management experience, including budget responsibility, with staff of similar size and technical level.
• Must have a minimum of 10-15 years of medical device experience in domestic FDA and an in-depth working knowledge of International medical device regulations and requirements.
• Experience should include close working relationships with business, marketing, manufacturing, legal and research functions, and an in-depth knowledge of domestic and international medical device and drug regulations and ISO 13485 quality requirements.
• Must have medical device experience within international markets.
• Experience with EU and/or other international medical device regulations.
• Extensive working knowledge of global regulations including EUMDR, ANVISA, COFEPRIS, etc.
• Experience as primary liaison to international regulatory authorities as well as experience authoring, reviewing and managing components of regulatory submissions is required.
• Ability to think strategically and critically evaluate risks to regulatory activities.
• Experience in a matrix organization and ability to negotiate across functional boundaries.
• Ability to influence supervisors, peers, and subordinates to drive innovation initiatives.
• Very strong communication skills (verbal and written); ability to explain technical information to non-technical people.
• Ability to travel international 25% of the time.

Preferred:

• MBA or advanced degree preferred; MS in Sciences / Regulatory Affairs, Engineering or Clinical Medicine a plus.
• Experience with GMP (QSR), with GCP/GLP a plus.
• Fluent Spanish a plus.

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.

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