Works under the direction of the operations team and is responsible for providing direct support to the QA Team and Operational Functions to achieve quality, efficiency, and cost targets, while ensuring compliance to all applicable standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Quality Assurance resource supporting activities and initiatives related but not limited to operational functions and materials control. For example, involvement in activities related to rework, in process inspections, document / records reviews and product release.
• Support activities, as needed, related to customer complaint investigation and sample / product analysis process.
• Support and serve as a resource for quality issues including but not limited to nonconformance failure investigations, assisting in establishing scope or extent of non-conformances (bounding/bracketing), assist in determination / completion of risk assessment, rework activities and product release.
• Work closely with QA lead in business related activities to ensure adequate operations support
• Support QA Team on a daily basis in related activities deliverables.
• Works in the different areas of Quality Assurance based on business needs.
• Supports Operational Functions, Quality, Engineering and others to ensure objectives are met.
• Supports Operational Functions, Quality, Engineering and others, as needed, in the implementation of corrections / corrective actions for identified issues, through the use of quality principles and data.
• Executes protocols as necessary.
• Performs 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 hold area.
• Completes records of inspection results, acceptance, rejection, and disposition of material.
• Interpret and execute statistical analyses, as needed, including but not limited to FMEA and SPC.
Support Operational Functions, Quality Assurance among others in continuous improvement activities as they relate to the reduction of product inquiries, efficiencies and or other 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.
• Provide materials/communication or service to customers in a timely manner.
• Recommends revisions, corrections, and changes to test equipment, procedures, and methods.
• Provide initiative to the QA organization through continuous improvement projects.
• Provide necessary feedback to customers.
• Fosters collaborative discussions with business partners regarding quality issues, projects, and activities as required.
• Manages varying circumstances and changing conditions as multiple situations may have to be addressed at the same time.
• Support / Provide coverage for absences as required.
• 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.
• General knowledge of medical devices preferred.
• Knowledge of Good Manufacturing Practices (GMPs) and ISO (International Organization for Standardization) policy And procedures is preferred.
• Basic computer skills and use of software applications.
EDUCATION & EXPERIENCE REQUIREMENTS
• High school diploma or equivalent required.
• Two to Four years of experience within manufacturing operations, preferably in the medical device industry.
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