We are seeking a Supplier Quality Engineer III  to join our team.

Job Purpose:

In this role you will be working with divisional products with cross-functional partners and suppliers to resolve quality issues and will play a key part in leading performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet company requirements.

It will also provide the opportunity to be involved in supplier related projects across the global supplier quality management network in the company. The role will require an element of travel as part of supporting and working with our suppliers.

Key Responsibilities:

• Responsible for quality performance of Sourced Finished Medical Device manufacturers (OEM and Contract Manufacturers)
• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, risk assessing, prioritizing, and resolving quality issues.
• Investigates and solves non-conformances due to incoming inspection at company Distribution Centers
• Supports investigation of material Quality issues/ complaints as they arise and ensures that adequate Corrective Actions are identified, implemented and controlled by Suppliers
• Reviews and approves supplier corrective action plans and verification of effectiveness documentation through SCAR ownership
• Plans and leads supplier assessment to assess compliance with regulatory standards and company requirements.
• Technical Team Member partnering with Supplier Engineering and Commercial Sourcing for multiple aspects of Supplier Management supporting objectives of the team in terms of Quality, Cost and Service including Supplier originated changes, design and labelling changes.
• Supports sustaining quality issues, process change impacts, and design change implementations for suppliers within their Quality system, and in the company Quality System.
• Team member of New Product Development (NPD) projects with responsibilities for execution of applicable SFMD Plan deliverables and collaboration with cross-functional new product development teams to onboard finished medical device suppliers.

Education & Experience:

• Level 8 Degree in an Engineering or Technical Discipline
• 4+ years of related work experience in the regulated industry including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA.
• Ability to work independently; organized and self-driven.
• A strong communicator (written and verbal) who can effectively organize, present and explains data/ information with all internal & external stakeholders.
• Competency in Microsoft software systems e.g. MS Excel, PowerPoint, Power BI and in QMS software systems (CAPA, SCAR etc)
• Domestic and international travel up to 25%.

Preferred Qualifications:

• Prior experience within a quality function, preferably supplier quality.
• Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements.
• Lead Assessor ISO13485 certification preferred.
• Familiarity with Drug coated products advantageous