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Principal Supplier Quality Engineer

Avanos

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Location:
United States

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

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

Requirements:

  • Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.
  • 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
What we offer:
  • comprehensive and competitive range of benefits
  • Total Rewards package
  • pay
  • health care benefits
  • retirement plans
  • work/life benefits
  • 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
  • benefits on day 1
  • free onsite gym
  • onsite cafeteria
  • HQ region voted 'best place to live' by USA Today
  • uncapped sales commissions

Additional Information:

Job Posted:
December 23, 2025

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