Director of Quality, Implantable Medical Device (Job ID:  172 DQ) 
Ann Arbor, MI 

This Director of QA will be responsible for directing and managing quality assurance, test, and document control functions within the respective manufacturing facility. This position must maintain full compliance to all FDA and ISO requirements and maintain efficient in the process and improving product quality. This position requires a minimum of ten years experience in the medical device industry such as pacemaker, implantable defibrillator, LAVD, LAVS Left ventricular assist device or other implantable class III devices. 

Primary Responsibilities:

• Manage all aspects of quality control and quality assurance including conformance of quality system to ISO9001, ISO 13485, ISO 14971 (Risk Management), GMP, AIMD (Active Implantable Medical Device), MDD standards as applicable, assessment and improvement of quality system
• Work with R&D and manufacturing to ensure internal groups and outside suppliers meet applicable quality standards. 
• Interface with other functions to analyze data and provide solutions for quality issues
• Develop and oversee of training program to ensure GMP compliance and internal training requirements
• Coaching and counseling of staff to focus efforts, clarify direction, and agree upon specific targets. 
• Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement..

Education Requirements:       

–   Certifications from ASQC, CQE or similar     

–   Bachelor’s degree in Science, Math or Similar     

–   Masters Degree Preferred 

Experience Requirements:

• Thorough knowledge of FDA regulations and ISO standards, i.e. ISO9001, ISO 13485, ISO 14971- Risk Management, GMP, IMD, AIMD (Active Implantable Medical Device), MDD. 
• Prior experience in manufacturing environment and regulatory exposure. 
• Strong background in statistics and biochemistry.  

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For additional information, please visit our website at www.LegacyMedSearch.com