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Job Title: Senior Quality Engineer
Industry: Medical Devices / Medical Device Regulations
Product Area: Neurovascular Products
Company/Product Reference: Cerenovus
Location: Cincinnati BMC, Ohio
Duration: 6 months
Experience Preferred: Minimum 5 years in Quality Engineering within the medical device or regulated life sciences industry.
Knowledge of Quality Management Systems (QMS) and applicable quality tools and techniques.
Knowledge of Good Manufacturing Practices (GMP), FDA Quality System requirements, ISO 13485, and applicable compliance regulations.
Knowledge of medical device regulatory standards, including design control and risk management requirements.
Experience with:
Nonconformance (NC) management
Corrective and Preventive Action (CAPA)
Deviation management
Root Cause Analysis (RCA)
Change control
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 (V&V) documentation and IQ/OQ/PQ activities.
Experience with Post-Market Surveillance (PMS) and quality trend evaluation.
Experience with PLM/eQMS tools; Windchill experience is preferred.
Understanding of engineering drawings, specifications, tolerances, and Geometric Dimensioning and Tolerancing (GD&T).
Experience supporting neurovascular, catheter-based, implantable, or other Class II/Class III medical devices is preferred.
Experience preparing and maintaining Quality Plans.
Experience supporting technical transfer and manufacturing transfer activities.
Experience providing QMS support, including internal/external audits and CAPA support.
Experience writing and revising Quality Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Strong written and verbal communication, problem-solving, planning, and project-management skills.
Proficiency in word processing, presentation, email, and spreadsheet software.
Ability to manage multiple priorities, meet deadlines, and communicate project status clearly.
Provide quality engineering support for Cerenovus neurovascular products throughout product development, design changes, technical 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.