Position Title: Supplier Quality Engineer
Location: Gainesville FL
Duration: 12 months
Supplier Quality Engineer
Perform Supplier Quality activities related to purchased part qualification with suppliers, supplier quality issue resolution and ensuring appropriate incoming material inspection strategies. Partner with Product Development and Manufacturing to adequately define Critical to Quality (CTQs) purchased parts. Plan, execute, and manage quality activities with suppliers, setting a high standard and fast response expectation so quality issues are prevented or minimized. Lead with best practices to enable our organization to provide high quality medical products to our customers.
•Manage Supplier Quality related activities for purchased materials for electro-mechanical commodities such as printed circuit board assemblies (PCA’s), power supplies, cables, battery packs, plastics, sheet metal, machined parts, OEMs (displays, medical assemblies), labeling, etc.
•Work with Development, Manufacturing, and External Suppliers to assess risks and define CTQs. Lead the Advanced Product Quality Planning (APQP) cross-functional team to provide the required deliverables in a timely manner.
•Work with suppliers to ensure all necessary quality activities are rigorously addressed during initial product release and change via APQP: process mapping, process FMEA, process control plan, process validation (IQ, OQ, PQ), GR&R, MSA, line release, ramp monitoring, etc. Ensure supplier test strategy aligns with quality goals. Support targeted and “at-risk” suppliers with new product introduction and facilitate from concept to launch whilst communicating and offering solutions for any potential risks identified.
•Focus on quality issue resolution via an 8-D based Supplier Corrective Action request process. Resolve quality issues via structured quality methods in order to ensure efficient and effective root cause analysis, and corrective / preventive actions that ensure there is no recurrence.
•Execute supplier audits, CAPA’s and monitor supplier metrics.
•Orchestrate Philips first article inspection / first production inspection, and ongoing inspection plans that are aligned with supplier’s capabilities, quality history and our product needs.
•Support key processes as subject matter expert.
To succeed in this role, you should have the following skills and experience
•BS Engineering degree and minimum of 5+ years industry experience in manufacturing of electro-mechanical systems/products/solutions for the medical, aerospace or automotive industries.
•Demonstrated knowledge of manufacturing processes for commodities such as printed circuit board assemblies, power supplies, cables, custom battery packs, mechanical parts (plastics, machined, sheet metal), cables, etc.
•Strong hands-on project management and teamwork skills with demonstrated ability to consistently establish and meet aggressive timelines. Demonstrated ability to build and maintain productive cross-functional and cross-organizational relationships on a global scale.
•Strong APQP knowledge and experience with all aspects of supplier quality management: quality concepts/tools/methods (e.g. FMEA, DOE, IQ/OQ/PQ, MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures ( use of statistical process control methodologies (CPk/PPk and data analysis is essential)
•Proven track record of developing suppliers & being part of a wider development team.
•Tenacity to getting things done and not accepting the norm, being adaptable to changing situations.
•Knowledge of the Purchasing function and associated commodity, supply base, quality and data management considerations. Understanding of Procurement, Supplier Relationship Management, Material and Supplier Quality and Data Management areas.
•Effective communicator. Able to work effectively with global, cross-functional stakeholders.
•Experience in a regulated environment, medical devices preferred.
•Certified auditor for ISO13485 or 9001.
•Knowledgeable in SAP Quality Management, Oracle Data Warehouse, Mini-Tab, Query tools such as Qlik, web-based systems, and MS Excel (power user).