Location: Santa Barbara
Posted on: November 25, 2018
Requisition ID: 41515 Title: Engineer - Supplier Division: Arthrex, Inc. (US01) Location: INC Santa Barbara, CA (ACT) (US17)
To manage and maintain 3rd party (e.g., private label, contract manufacture) supplier base to assure products and processes internally and externally meet specifications, improve supplier product quality performance, and determine adequate receiving inspection plan.
Essential Duties and Responsibilities:
- Responsible for reviewing processes with suppliers to assure product reliability and quality
- Work with suppliers to improve product and process quality through onsite workshops, development of PFMEAs / Control Plans, and assist with correlations studies and inspection plans.
- Review and engage with supplier process improvements, process validations, supplier initiated change notifications, and FAI expectations to assure processes are adequate to meet specification.
- Assisting in compiling and reporting on supplier performance metrics / statistics.
- Evaluate and assist in determining reduced or increased inspection plans based on supplier performance and controls.
- Initiate and assist suppliers with Corrective and Preventive Actions and assure actions are adequately closed.
- Work closely with the Supplier on implementing the product Service Support Plan through creating processes and SOPs that coordinate and synergize the technical services activities of Arthrex and Suppliers' teams
- Assist in the design and development of methods and tooling for the test and inspection of articles.
- Work with supplier to ensure that suppliers operate in accordance with established requirements.
- Responsible for assisting in complaint investigations as related to product quality from suppliers.
- This role requires 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; preferably in Industrial Engineering
- 3 years engineering work experience required, preferably in the medical device industry
- 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), First Article Inspection (FAI), Incoming Inspection Plans (IP), and supplier audits
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Knowledge of validation methods, problem solving, and control plans.
- Must possess practical knowledge related to the products/components that the position will support, e.g., electromechanical product components and assembly processes.
- Must have competent PC skills and be highly proficient with Microsoft Word, Excel, and PowerPoint.
- Must have practical knowledge and experience in statistical analysis, problem-solving/process improvement techniques, and Root Cause Investigation/CAPA.
- Familiar with the proper use of common inspection tools, test equipment, and visual standards.
- Must be able to read and understand component/product specifications.
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.
Keywords: Arthrex, Santa Barbara , Supplier Engineer, Engineering , Santa Barbara, California
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