Engineer Sr - Service Supplier
INC Santa Barbara, CA
To qualify our potential and existing external medical devices suppliers. Perform supply quality and on-time delivery issue resolution. Lead supplier performance evaluation and supplier development activities, including being the liaison between internal functions of Service and Repair, Quality, Supply Chain and Engineering to our key service suppliers, in order to optimize the quality, cost and delivery of our suppliers' services.
Essential Duties and Responsibilities:
- Supplier Quality: Partner up with Supplier Quality Engineering (SQE) team to ensure that an effective Quality Management Systems are in place at our service suppliers. Support supplier root-cause investigations and corrective actions for major quality issues as it relates to product and/or service performance
- Supplier Development: Develop and support targeted service suppliers to achieve conformance with Arthrex requirements and continual improvement in quality, delivery performance and cost control/reduction. The decision to develop a supplier should be done in close cooperation with concerned internal functions, and should leverage scorecards to drive the supplier to achieve continuous improvements against metrics
- Supplier assessment (audits): Plan and conduct or support required service supplier assessments including assessment reporting and non-conformance reporting. Verify effective closure of assessment non-conformances by the supplier and support where applicable
- Supplier Performance evaluation/monitoring: Monitor and report service supplier performance (KPIs), quality issues and development actions. Initiate and lead required Supplier Performance Evaluations (SPE) and secure that the results are shared for follow up with the supplier. Provide support to the supplier, where applicable, in performance and capacity improvement activities
- Interface with other functions: This role requires close cooperation with Service and Repair, Supplier Quality Engineering, Supply Chain, Quality Assurance, R&D/Engineering, and possibly other teams. It requires also to represent the “Voice of the Supplier” to Arthrex and related functional areas as described above
- Identify, qualify and develop new suppliers
- Reviews and approves scope, budget and schedule of project assignments
- Assists senior management and staff as a subject matter expert for dealing with service suppliers issues
- May Supervise, lead and direct engineers, technicians or service personnel
- Ability to travel up to 50% of the time
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
- BS in Engineering required;
- 7 years work experience as a supplier engineer required
- Practical experience/familiarity with regulated environments, i.e. ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, ISO 14971 and other applicable standards required
- Must have relevant experience with supplier quality systems/processes including Supplier Corrective Actions (SCAR), and supplier audits
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Project management experience, including data handling, documentation and decision-making.
- Previous supplier development experience
- Ability to communicate effectively, both orally and in writing, at a variety of technical levels
- Ability to work effectively as part of the diverse team in a fast-paced environment and with multiple projects
- Ability to work on a variety of problems of diverse scope and complexity where analysis and evaluation of various outcomes require tradeoffs and negotiation.
- Ability to work effectively with standard business applications software and/or specialized data analysis tools systems or other computer aided design/manufacturing systems.
- Ability to read, analyze, and interpret engineering drawings, technical policies and recommend changes to procedures.
- Must have practical knowledge and experience in statistical analysis, problem-solving/process improvement techniques, and Root Cause Investigation/CAPA.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), PowerPoint, Visio, Minitab, Outlook, and, SAP or similar ERP software.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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