Descripción del Trabajo
Works under the direction of the Quality Assurance Organization and is responsible for providing support and leadership to the QA Team and the manufacturing operation to achieve quality, efficiency, and cost targets, while ensuring compliance to all applicable standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Product certification and final product release, including but not limited to packaging and sterilization.
• Quality Assurance resource supporting activities and initiatives related but not limited to manufacturing operations, materials control, packaging, sterilization, and distribution.
• Coordinate activities related to the customer complaint investigation and analysis process.
• Provide leadership of activities and serve as a resource and/or subject matter expert for quality issues including but not limited to holding product, establishing scope or extent of nonconformances (bounding/bracketing), risk assessment, failure investigations, and product release.
• Provide coaching and mentoring of QA Technicians under the direction of the Quality Assurance
• Provide Quality Assurance product certification for EES-Albuquerque operations.
• Assist Engineers with audits to assess compliance to GMP, ISO, and EES standards.
• Support QA Team on a daily basis.
• Works in the different areas of Quality Assurance based on business needs.
• Coordinates discussions with Quality, Engineering, and other business partners to ensur department objectives are met.
• Partners with Quality, Engineering, and other business partners to develop corrective actions for reoccurring problems, through the use of quality principles and data.
• Writes and executes protocols as necessary.
• Performs complex tests and data analyses to recommend disposition of material.
• Responsible for monitoring and reporting QA holds.
• Responsible for the control and monitoring of the QA Cage.
• Perform inventory verifications and transactions for material and finished goods as required.
• Completes records of inspection results, acceptance, rejection, and disposition of material.
• Conducts statistical analyses including but not limited to GR&R, Capability, FMEA, and SPC as required.
• Coordinates all activities related to the Customer Complaint Investigation and Analysis process including but not limited to receiving instruments, scheduling complaint analysis, input of analysis findings into complaint database, review and approval of analysis results, keeping accurate and up to date complaint records, and disposition of instruments after analysis.
• Provide support as needed to manufacturing operations to determine the root cause of product inquiries.
• Provide support to Business Unit and QA Engineers in continuous improvement activities as they relate to the reduction of product inquiries or other COGS initiatives
• Maintain knowledge of all procedures, change to specifications (Process, Training Manuals, Material Specifications, etc.), and regulations related to their area of responsibility.
• Maintain process knowledge for the assigned area of responsibility.
• Works with QA Engineers on document and process improvements, including but not limited to data collection, ECN’s, and additional training as required.
• Provide materials/communication or service to customers in a timely manner.
• Recommends and implements revisions, corrections, and changes to test equipment, procedures, and methods.
• Provide leadership and initiative to the QA organization through continuous improvement projects.
• Provide necessary feedback to customers.
• Coordinates discussions with business partners regarding quality issues, projects, and activities as required.
• Exercise initiative and ingenuity to deal with varying circumstances and changing conditions, referring unusual situations to QA Engineers.
• Provide leadership with project completion and project enhancements.
• Provide/coordinate coverage for absences as required.
• Provide leadership to team as appropriate.
• Work cooperatively toward effective outcomes.
• Work to resolve differences in a collaborative effort.
• Follow all company safety policies and other safety precautions within the work area.
• Promote safety to all associates that enter the work area.
• Attend required safety training
• Participate in implementation of the EMS management system including continual improvement, pollution prevention, objectives and targets, and regulatory compliance.
• Implement and follow all applicable EMS procedures.
• Adhere to the site’s EHS Code of Conduct.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Knowledge of product and process specifications.
• Knowledge of test and inspection methods, i.e. Presumptive test, Dye test, and others as applicable.
• General knowledge of medical devices preferred.
• Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
EDUCATION & EXPERIENCE REQUIREMENTS
• High school diploma or equivalent required.
• ASQ Certification (CQA or CQT) or Internal Auditor Certification preferred.
• Six-sigma certification preferred.
• Four to six years of experience with manufacturing operations, preferably in the medical device industry.
• One to three years of Quality Assurance experience is preferred.