תיאור המשרה | • Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Support, review and approval of Validation, MSA, Control Plan, PPAP, etc. deliverables from suppliers related to product introduction or transfers.
• Manage supplier monitoring and performance including non-conformances, CAPA, SCAPA, and complaints.
• Support the Quality Engineering team to improve and maintain an effective and efficient Supplier Quality process to support the finished goods product.
• Evaluation of component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations.
• Support CM led Process FMEAs (pFMEAs) in a manufacturing environment for subsystems within the Minimally Invasive Surgical System.
• Manage communication of CM and sub-supplier deviation requests pre-process validation activities.
• Ensure proper approval, documentation and communication practices are followed for any Supplier Change Request at CMs.
• Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions.
• Ensure the development of and compliance to Process Flows, Control Plans, Measurement Systems Analyses, Process monitoring, and Validation processes.
• Interact and form constructive working relationships with all levels of leadership within the Contract Manufacturer’s Quality, Procurement, Marketing, R&D, and Operations.
Job Qualifications:
• Self-starter with go get it attitude and strong interpersonal skills
• Strong MS Office skills
• Effective oral and written English communication skills
• Strong writing skills (Supplier Qualification requirements, Mfg. Instruction creation etc.)
• Supplier quality issue resolution
• Process Validation and ongoing manufacturing activities of a commercialized medical device.
• Works directly with suppliers and contract manufacturing in all aspects of Product and Process development, release, and sustaining activities
Education
• Required: Bachelor’s degree in Engineering/Scientific/Electronic or technical field.
Experience:
• 2-year experience in engineering practice.
• Demonstrated Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, FDA, ISO9001, 13485 requirements.
• Familiarity with SPC, Product Design, Process validation, and Lean manufacturing/Six Sigma concepts and understanding.
• Strong MS Office skills
Working Environment:
• Usual office environment with frequent (Between once and twice a week) visit at suppliers and contract manufacturing
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