Principal Supplier Quality Engineer

Requisition

Job Title:
Principal Supplier Quality Engineer

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 .

Essential Duties and Responsibilities:

Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures.

This position provides technical leadership for Supplier Quality Management processes and activities. The primary purpose of this position is to implement, coordinate, support, and monitor activities related to the Global Supplier Quality Management (SQM) activities across Avanos. This position may also train R&D, Technical Quality, Operations, and other functions on the established processes and any enhancements as needed and perform other additional duties as assigned..

Key Responsibilities:

• Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices to ensure the manufacturing and distribution of products comply with applicable regulatory requirements.
• Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers.
• Establish and administer the supplier audit program for quality/regulatory compliance.
• Maintain the Approved Supplier List (ASL).
• Support the Global Supplier Review Board, including providing metrics for
• supplier assessments.
• Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits.
• Provide guidance as needed for corrective action required because of assessment findings.
• Execute supplier audits in accordance with approved schedules.
• Support documentation of supplier changes through the supplier notification, change management, QNC, or CAPA processes.
• Contribute to the supplier qualification vetting process and perform supplier evaluations to ensure appropriate suppliers are being selected.
• Continuously improve existing Supplier Quality Management Process to ensure compliance with regulatory requirements.
• Develop, implement, and execute a system for conducting due diligence evaluations for supplier qualifications and acquisitions.
• Provide auditing support during due diligence and integration activities as needed.

External Interface:

This role will primary interface externally with suppliers and with external auditors from Notify Bodies and Regulatory Agencies

Your qualifications

Required:

• Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.

Preferred:

• B.S. in Engineering, Science, Business, or another relevant field
• Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry.
• Supplier Quality Engineering experience in the Medical Device industry
• Strong understanding of Risk Management principles and techniques.
• Knowledge of Statistical Techniques
• Experience in root cause analysis and failure investigation tools
• Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
• Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
• Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor
• Strong project management skills
• Ability to make reasonable decisions and be able to effectively justify them
• Strong collaborative skills and customer service approach
• Exceptional written, verbal, and presentation communication skills

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification.…