Sr. Director Quality

* Implement and maintain programs and processes to ensure high quality products and compliance with the QSR and ISO 13485
* Hire, develop and mentor employees to create a world class Quality Organization
* Review and interpret regulatory quality system rules and ensure that they are communicated accurately through company policies and procedures
* Work directly with and/or influencing operating entities to ensure that the quality system program is robustly effective across the organization ensuring Company compliance and success.
* Lead in the identification, development, implementation and continual improvement of quality systems across regulated areas of the company
* Establish quality plans as required
* Act as primary liaison and direct interactions with FDA, State Department of Health and notified bodies during company inspections
* Serve as the QSR/ISO Management Representative; organize routine management review meetings and serve as primary liaison with Executive Management and Board of Directors related to Quality issues.
* Generate and maintain the quality policy, quality manual and quality objectives
* Establish and maintain a company-wide QSR/ISO 13485 training program
* Oversee complaint handling, CAPA, training, equipment calibration and preventive maintenance programs
* Manage internal audit program; act as Lead Auditor
* Oversee the supplier evaluation and audit program; Interface with contract manufacturers to establish and nurture relationships associated with quality oversight
* Develop and maintain facilities, equipment, and procedures for testing and analyzing incoming materials
* Oversee final release activities for all manufactured commercial products and clinical materials, including review of manufacturing, environmental monitoring, and quality control data
* Conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products as needed
* Direct and/or participate in work with Design Engineering teams on risk management and design control activities in support of new or next generation products
* Direct development and implementation of automated systems to manage quality records
* Participate on Change Control Board; approve all new and revised production-related documents
* Write and/or implement changes to controlled documents (e.g., SOPs, Work Instructions, etc.), as needed
* Ensure current standards and regulatory compliance guidance documents are readily available to the organization
* Coach and develop QA department employees; act as advisor to assure timelines are met and issues are resolved
* Develop and administer department budgets, objectives, schedules, training plans and performance reviews
* Procure and manage outside vendors and consultants as required

REQUIREMENTS:

* B.S. in life sciences, engineering, or equivalent required; MS preferred
* 10+ years related experience in the medical device industry; 5+ years in a management role
* Extensive knowledge of Quality Systems including QSR, MDD, and ISO 13485:2003
* ISO Lead Auditor training
* Solid organizational, analytical and problem solving skills
* Excellent interpersonal and communication skills, both verbal and written
* Additional peripheral experience in Manufacturing, Engineering and/or Product Development is preferred
* ASQC membership preferred

To find out more about Real Staffing please visit www.realstaffing.com