186 Sr. Quality Assurance Engineer, Orthopedic Implants (Job ID: 186 SQA – CQA - Engineer)  

This position  will be  interfacing with development engineers and other development team members or end users to ensure product quality requirements are met, participating in verification and validation activities, reviewing DHF design history files, CAPA and complaint handling and standardization, internal and supplier audit, appropriate design control and related documentation, and supporting regulatory approvals and technical file development.  Responsibilities also include support to Product Development, Research/Testing, Manufacturing, Regulatory Affairs and Quality Assurance.  Emphasis is on executing these tasks with consideration and adherence to GMP and ISO requirements. 

Primary Responsibilities :

 ·               Manage the Internal Audit and Supplier audits systems

·               Maintain and Improve CAPA Systems, writing SOPs, Action Plans

·               Work with Customer Feedback and MDR reporting

·               Work with risk management and quality requirements throughout the product development process.

·         Review design history file to ensure quality system requirements are implemented and documented properly.

·         Support Quality Assurance inspections and function.

·         Participate with Material Review Board to address complaints and assign CAPA. 

·              Provide appropriate documentation to support regulatory submissions, ISO certification and Quality System adherence

Qualifications :

• Bachelor’s degree in engineering field or similar background.
• 8+ years in working in Quality of Compliance Function of Class 2 and/or Class 3 implantable medical devices
• Knowledge of regulations/standards applicable to spinal implants, instruments, and human tissue products.
• Basic notion of Japanese and Canadian regulations.
• Experience in medical quality systems.
• Knowledge of CAPA and quick response to identified non-conformances.
• Experience acting as an independent QA reviewer of Customs dossiers.
   

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ABOUT Legacy MedSearch:

Retained Recruiting Firm specializing in the Emerging Medical Technology. Our firm is hired by medical device and imaging manufacturers to find senior-level executives in specialized fields such as surgery, diagnostic & therapeutic imaging & radiology, including CT, MR, PET, DR/CR, Ultrasound, HIFU, Fluoroscopy, PACS, Mammography, MIS & LIS procedures. We work with manufacturers of a variety of implants & technologies: IMD, AIMD and Class I, Class II and Class III devices with special emphasis on orthopedics, Navigation (IGS, CAS, DBS, Surgical Robotics, NeuroScience), neurosurgery, radiology, neuroscience, cardiology and cardiovascular and other emerging medical technology (VC, PMA, 510(k) & IDE device classes).
Our office recruits: Product Managers, Engineers (Product Development, Design, Manufacturing, Electrical and Software engineers), Marketing and Sales Executives, Operations, Quality, Regulatory, Research Professionals. 

In the past 18 months, we have placed 48 professionals in start-up, emerging & leading medical companies. For additional information, please visit our website at www.LegacyMedSearch.com