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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 technical leadership for Supplier Quality Management processes and activities
Implement, coordinate, support, and monitor activities related to the Global Supplier Quality Management (SQM) activities across Avanos
Train R&D, Technical Quality, Operations, and other functions on the established processes
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices
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
Continuously improve existing Supplier Quality Management Process
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
Requirements:
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
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