Accountabilities and Ownership

• Directs the development, implementation, management and continual improvement of an effective quality system
• Manages the QA department with oversight of daily activities
• Supports/leads design control, test plan definition, process validation, and supplier evaluations
• Serves as a quality system and regulatory resource to the organization by providing counseling and oversight that are in compliance with applicable standards and regulations
• Consults with internal/external customers on compliance and regulatory issues
• Maintains competency in FDA quality system regulations and ISO 13485 standard
• Performs reviews of protocols, data and reports to ensure compliance with Quality System and applicable regulations and/or standards
• Conducts internal quality auditsPerforms supplier qualification assessments and audits
• Functions as administrator of non-conformances/deviations and CAPA systems
• Develops and maintains an archive of documents and procedures; submits documents and/or reports to regulatory agencies as required
• Administers and monitors employee training compliance
• Possesses overall responsibility for equipment preventative maintenance and calibration programs
• Oversees the implementation and on-going maintenance of production and process controls
• Manage design control elements including development of design verification and validation program
• Leads risk management activities
• Ensures all requirements are successfully met for initiation of clinical trials
• Trains staff on quality procedure and protocol

Reports to: CEO

Experience

• 8-12 years experience establishing, implementing and directing a best-in-class QA program; 3+ years in a management role
• ISO13485 and ISO9001:2008
• FDA/R&D environment experience desired
• Class III medical device experience preferred
• Start-up experience strongly desired

Education: Bachelors degree in quality or related; Masters degree helpful

Traits desired: Organized, adaptable, self-directed, collaborative work style