Principal Supplier Quality Engineer

Principal Supplier Quality Engineer

Location:

United States (US)

Here at Avanos Medical, we passionately believe in three core values: making a difference in our products and services, collaborating in a nimble culture of innovation, and impacting healthcare challenges worldwide.

• Ensure conformance to industry practices, domestic and international regulatory requirements, and company procedures.
• Provide technical leadership for Supplier Quality Management (SQM) processes and activities across Avanos.
• Implement, coordinate, support, and monitor global SQM activities.
• 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 and maintain the Approved Supplier List (ASL).
• Support the Global Supplier Review Board by providing metrics for supplier assessments.
• Engage with suppliers on corrective actions or upcoming external audits and provide guidance for corrective action when needed.
• Execute supplier audits according to approved schedules and support documentation of supplier changes through notification, change management, QNC, or CAPA processes.
• Contribute to supplier qualification vetting, perform evaluations, and continuously improve existing supplier quality processes.
• Develop and execute a system for conducting due diligence evaluations for supplier qualifications and acquisitions, and provide auditing support during due diligence and integration activities.

This role will primarily interface externally with suppliers and external auditors from notified bodies and regulatory agencies.

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

• B.S. in Engineering, Science, Business, or a relevant field.
• Minimum of 10 years of experience in research, manufacturing, quality, or regulatory affairs within a 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 with root cause analysis and failure investigation tools.
• Working knowledge of the MDSAP Single Audit program and key medical device compliance 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 and the ability to make justified decisions.
• Strong collaborative skills and a 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. They are not an exhaustive list of all duties, responsibilities, and skills required.

Avanos Medical is an equal‑opportunity employer. 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 or a current Avanos Contractor, please apply here.

• Generous 401(k) employer match of 100% of each pretax dollar contributed on the first 4% and 50% of the next 2% with immediate vesting.
• Free onsite gym and cafeteria.
• Uncapped sales commissions.
• Competitive health care benefits, retirement plans, and work/life benefits.
• Day‑1 benefits.

Make your career count by making a difference in products, solutions, culture, and the lives of people and communities worldwide.