Quality Engineer

2 weeks ago

Fremont, United States Katalyst Healthcares and Life Sciences Full time

Summary: Responsible for ensuring that materials, goods, and services meet Customer and Quality requirements. Maintains the Quality System to comply with regulatory requirements. Leads continuous quality improvement activities. This is a hands-on position that works with Customers and all functions and levels within the company. Job Description: Quality Management System Maintain the Quality Management System procedures and work. instructions to comply with Customer and Quality/Regulatory requirements. Work with all functions to ensure compliance with requirements. Supplier Management Manage the Supplier Management program. Initiate Supplier Evaluations and perform Supplier Approvals Conduct Supplier Audits Maintain the Approved Supplier List Develop Supplier Quality Measures and work with Suppliers to improve performance. Maintain an effective Supplier Corrective Action process. Identify opportunities for supply chain improvements. Implements process. improvement to increase quality and yields at suppliers. NCMR Manage the Non-Conforming Materials Process Works with Customers, Suppliers, and internal personnel to resolve. nonconforming materials issues Prepare non-conforming material reports and participate in subsequent. root cause investigation and corrective action planning. Incoming Inspection Participate in and support the Incoming Inspection function. Develop incoming Inspection requirements. Manages the Calibration and Preventive Maintenance process. Coordinates the calibration of equipment with the Calibration Service Works with personnel and Customers to ensure that all equipment is calibrated and maintained. Ensure that all internal calibrations are performed per requirements. Participate in New Product Introduction teams to ensure customer and regulatory requirements are met. Manage the Corrective & Preventive Action System including responding to Customer Complaints Develop and prepare QMS metrics to monitor the performance of internal. processes for Customers, and Management Manage the Document Control process for Quality Management System documentation. Prepare materials for, and participates in Management Reviews Facilitate the Internal Audit program and conduct audits of the QMS. Facilitate and manage Customer, Notified Body, and Regulatory Audits Work with all functions to ensure Training is conducted per requirements. Performs Release to Finish Goods and Authorizations for Distribution Drives improvements by facilitating cost and quality improvement projects. Knowledge and Skills: Demonstrated ability to work well in a cross-functional team environment and clearly communicate the status of assigned projects. Ability to work under tight deadlines and to handle multiple detail-oriented tasks simultaneously. Excellent oral, written, and people skills. Demonstrated high level of computer literacy - proficient in developing. spreadsheets, utilizing word processing and databases (MS Office) Proficient in performing Corrective and Preventive Actions Proven analytical ability and attention to detail. Ability to work proactively with suppliers to improve product quality and quickly. resolve quality issues. Understand and be proficient in the use of incoming inspection equipment. Knowledge of theory and application of principles of statistics, statistical sampling techniques, and statistical process control. Knowledge of, and experience with sterile medical device controls and requirements would be a benefit. Education and Experience Bachelor degree in Engineering, prefer Industrial, Manufacturing, or Mechanical 5 plus years of Quality Engineering experience Required Medical Device Experience Comprehensive knowledge of ISO 13485 and 21CFR820 Auditing experience is required. In addition, experience with the following would be beneficial: Contract Manufacturing Lean Manufacturing Process Validations Software Validation Risk Management AS9100 ITAR RoHS

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