Senior Supplier Quality Engineer
• Reporting to the Senior Manager, Global Supplier Quality, the Senior Supplier Quality Engineer is a member of a Global Supplier Quality Team and the primary contact for the Global Procurement and Site/Business Unit Quality Team (s) in relation to Supplier Quality tasks. The role will coordinate with Global Procurement and Site/Business Unit Quality to provide the appropriate supplier quality support for the purchase of Commodities, Purchased Finished Good(PFG’s) and Critical Services.
• Lead large scale supplier quality improvement projects
• Assist with the development of suppliers to provide reliable, trustworthy and productive relationships
• Primary contact to assigned Global Procurement and manufacturing site(s)/Business Unit (s)(BU) for the resolution of supplier issues, new projects, and new acquisitions
• Serve as a subject matter expert in Purchasing Controls
• Develop, coordinate, track and review Supplier Quality Agreements
• Perform supplier facility compliance audits
• Develop strong partnering relationships with Global Procurement, Supply Chain, QA/RA, Design, and Manufacturing groups
• Perform supplier compliance and qualification functions and activities for prospective new Commodities, Purchased Finished Goods and Critical Service suppliers.
• Work with Global Procurement and Site/BU Quality on the selection and development of key and critical suppliers to improve supplier’s performance, quality, cost, responsiveness, and technology.
• Perform supplier development activities with suppliers of defective materials including developing and executing Supplier Quality Plans, conducting “For-Cause” Audits, Supplier Corrective Action follow-up, coordinating Business Reviews, and implementing Six-Sigma and Continuous Improvement methods and techniques.
• Resolve ineffective supplier corrective action plans with suppliers.
• Implement quality improvement issues related to suppliers of materials, products, or critical services in development or manufacturing.
• Coordinate component and purchased finished goods quality testing.
• Coordinate supplier change requests and develop and implement appropriate strategies to support
• Analyse and identify trends from quality data and develop proactive measures with supplier in support of continuous improvement.
• Lead supplier related activities in support of business objectives
• Assist the organisation with the acquisition of new companies and the integration of their suppliers into the Organisations Quality System.
• Serve as subject matter expert in problem solving methodologies and provide training to different levels of the organization on problem solving methodologies/root cause analysis and to develop investigation skills where required.
• Provide other departmental support requested by immediate Manager.
EDUCATION / EXPERIENCE REQUIREMENTS:
• Bachelor’s Degree preferably in a scientific/engineering/technical field
• 5+ years of experience working within an FDA regulated and ISO 13485 industries preferably in medical device design, quality, quality engineering or manufacturing
• Advanced problem solving and root cause analysis experience in a manufacturing environment.
• Demonstrated knowledge and experience in: supply chain management and supplier development, risk/issue management, implementation planning, training/communication, scope management.
• Working knowledge and auditing experience to US and international regulatory and quality assurance requirements (FDA 21 CFR Part 820 and ISO 13485) associated with the development and manufacture of medical devices or drug products
• Demonstrated track record of effectively influencing and negotiating with suppliers and leading effective/successful change initiatives
• ISO-13485 Lead Auditor certification preferred
• Advanced statistical techniques knowledge.
• Advanced knowledge of ISO 13485 & QSR 21 CFR Part 820
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
• Excellent verbal and written communication skills
• Excellent technical writing skill
• Experience with Visio, Access, Microsoft Word, Excel, PowerPoint, statistical applications
• Excellent training presentation skills
• Project Management and team facilitation skills
• 6 Sigma and/or Lean experience an advantage
• Experience working remotely and in a multiple projects environment
Clodagh Nerney | Tel: +353 (0) 1 507 9254