QM with GMP,FDA

Title: Quality Manager with GMP,FDA

Location: Cincinnati, OH

Job Type: 6 Month Contract

Pay Rate: $45/hr to $52/hr on W2

Must Have Technical/Functional Skills

• Knowledge of Quality Management Systems and applicable quality tools and techniques
• Knowledge of GMP, FDA Quality System requirements, ISO 13485 and applicable compliance regulations
• Knowledge of medical device regulatory standards, including design control and risk management requirements
• Knowledge of NC, CAPA, deviation, Root Cause Analysis, change control and audit processes
• Knowledge of statistics, Risk Management, Design Control and process validation
• Experience creating and reviewing DFMEA, PFMEA, risk management records, protocols and technical reports
• Experience with verification and validation documentation and IQ/OQ/PQ activities
• Experience with Post Market Surveillance and quality trend evaluation
• Experience with PLM/eQMS tools; Windchill experience is preferred
• Good understanding of engineering drawings, specifications, tolerances and GD&T
• Experience supporting neurovascular, catheter-based, implantable or other Class II/Class III medical devices is preferred Strong written and verbal communication, problem-solving, planning and project-management skills Proficiency with word processing, presentation, e-mail and spreadsheet software Ability to manage multiple priorities, meet timelines and communicate project status clearly Experience preparing and maintaining Quality Plans Experience supporting technical transfer (tech transfer) and manufacturing transfer activities Experience providing QMS support, including internal/external audit and CAPA support Experience writing and revising Quality SOPs and Work Instructions (WIs)

Roles & Responsibilities

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Client procedures and guidelines, the duties and responsibilities for this position are:
• Provide quality engineering support for Cerenovus neurovascular products throughout product development, design changes, technical transfer (tech transfer), manufacturing transfer and sustaining activities
• Prepare, develop, review, maintain and approve Quality Plans and Product Development Process deliverables, including protocols, reports, specifications and engineering documentation
• Review and approve R&D/Engineering verification and validation protocols and reports
• Develop and maintain risk management records, including DFMEA and PFMEA, in collaboration with subject matter experts
• Support and provide quality guidance for process validation and equipment qualification activities, including IQ, OQ and PQ
• Provide Quality Management System (QMS) support and maintain Quality documentation to ensure objective evidence is complete, accurate and traceable
• Lead or support audits, Root Cause Investigations and closure of nonconformances, deviations and CAPAs; support audit responses and verify effectiveness of implemented corrective and preventive actions
• Review and approve Change Orders, including CR/CN documentation, and assess product, process, quality and regulatory impact
• Apply statistical methods to process and product data, including capability analysis, sampling rationale and measurement system assessment, as applicable
• Support post-market quality activities, complaint trending and design or process enhancements
• Write, review, revise and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs) for Quality functions
• Interpret new or upcoming quality and regulatory requirements and provide guidance to cross-functional teams
• Partner with R&D, Manufacturing, Regulatory, Operations, Supplier Quality and other internal teams to create and approve deliverables

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