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Avanos Medical · 1 day ago

Principal Supplier Quality Engineer

Atlanta Metro

Full-time

Onsite

Lead/Staff

10+ years exp

Avanos Medical is a medical device company focused on delivering clinically superior breakthrough solutions. The Principal Supplier Quality Engineer will provide technical leadership for Supplier Quality Management processes and ensure compliance with regulatory requirements while collaborating with various teams to address quality issues.

Health CareHospitalHospitality

Responsibilities

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

Qualification

Supplier Quality EngineeringRisk ManagementStatistical TechniquesMDSAP Single AuditISO Standards KnowledgeCQA CertificationProject ManagementCustomer ServiceCollaborative SkillsCommunication Skills

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