Summary

The Director of Quality Assurance will oversee staff and operations for all Quality Assurance functions including QA Operations, Quality Management Systems, QA Auditing and Compliance, Risk Management, Inspection Readiness and Product Development. The Director of Quality Assurance is also responsible for assuring operational compliance with governmental rules and regulations governing the development, manufacture and sale of medical devices and their accessories; establishing, maintaining and monitoring systems conforming to applicable FDA, European, notified body and customer requirements.

Specific Duties

• Provide leadership and guidance for all QA functional managers and direct reports.
• Responsible for the Quality Assurance department (including QE and QC) and the development and execution of departmental goals/objectives.
• Create and manage all departmental budgets.
• Oversee hiring, training, management and development of all direct and indirect reporting employees.
• Support regulatory inspections, GMP compliance audits and regulatory filings.
• Direct and manage the company’s compliance with all pertinent FDA, MDD, other applicable regulations and customer expectations governing the development, manufacture and sale of medical devices in the United States and overseas. This includes obtaining copies of all current regulations and specifications applicable to the devices group/product division systems, markets and products.
• Direct and manage the company’s compliance with European and other international requirement s to allow the approval, development, marketing and sale of devices outside the continental United States.
• Oversee company’s customer interaction records, complaints records and adverse events reporting, including the investigation and reporting of those events to the responsible regulatory bodies.
• Provide quality oversight for suppliers and contract manufacturers to ensure all change controls and investigations meet the company quality standards.
• Identify and report to senior management any quality and regulatory risks.
• Assure that company’s documentation required for complying with the FDA, MDD and other medical regulatory requirements is adequate, controlled and maintained as prescribed by the appropriate regulations and/or customer requirements.
• Lead the validation program including process, equipment and computer system validations.
• Serve as the QA representative on product or project teams within the Devices Group.
• Act as an engineering resource when applicable on manufacturing, design and product development teams.

• Bachelor’s Degree in Engineering or related technical field.
• Minimum of ten years’ experience in a technical field with at least seven documented years of Quality Assurance and Quality Control background in a highly regulated environment.
• Pharmaceutical/Medical Device combination product experience.
• Experience with and understanding of ISO 13485 regulations.
• Previous experience interacting with/hosting Regulatory/Health authorities.
• In depth knowledge of quality systems design and implementation.
• Good working knowledge of statistical and non-statistical quality improvement tools.
• A minimum of three years’ relevant management/supervisory experience.
• High degree of professionalism with the ability to communicate well both verbally and in writing.
• Ability to travel 15% both domestically and internationally.