Quality Assurance (Job ID: 166 QA)

Location: Austin, TX

Position Summary:

This position will work in support of the development and production of implantable medical devices and implants and related instrumentation. Responsibilities will include interfacing with development engineers and other development team members or end users to establish product quality requirements, coordinating risk management, participating in verification and validation activities, developing packaging and instrument systems, reviewing design history files, 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 through the design of packaging and instrumentation systems, production fixtures and tooling and inspection tooling.  Emphasis is on executing these tasks with consideration and adherence to GMP and ISO requirements. 

 Education:  

Minimum of a bachelor’s degree in Mechanical Engineering or related field in quality, product development or manufacturing engineering. 

Experience Requirements:   

• 7+ years in manufacture of implantable medical devices
• Knowledge of ProEngineer software and manufacturing required.
• Knowledge of GMP, ISO and quality system practices required
• Experience with new product development strongly preferred

Responsibilities: 

• Work with Development Engineering and other functional areas to establish quality requirements for devices to be manufactured. 
• Work with risk management and quality requirement throughout the product development process.
• Review design history file to ensure quality system requirements are implemented and documented properly.
• Provide appropriate documentation to support regulatory submissions, ISO certification and Quality System adherence.       
• Work with others within the Manufacturing and Development group to develop product specifications, drawings and related design output.
• Manage packaging and instrument systems appropriate to sterilization requirements.
• Support manufacturing process development during product development process.
• Provide engineering support for product after Design Transfer.
• Participate with Material Review Board to address complaints and assign CAPA.
• Support Quality Assurance inspections and function.
• Work with and facilitate vendor qualification and approval process. 
• Provide drawings and documentation to outside vendors to facilitate production of parts and instrumentation.

Click here to apply online

You can email resumes to Admin@LegacyMedSearch.com 

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