Associate Director, Product Quality

Essential Duties and Responsibilities.  

• Develop and implement the company's quality control and product quality strategies, ensuring alignment with industry best practices and business objectives.
• Serve as a technical leader and oversee the implementation and maintenance of a robust product qualitysystems, including manufacturing processes, quality control, validations, nonconformances and supplier quality.
• Manage the QC and Product QA teams, providing guidance, mentoring, and support to ensure high performance and adherence to quality standards.
• Lead and coordinate quality control activities, including the inspection, testing, and release of raw materials, components, and finished products.
• Establish and monitor quality control metrics and key performance indicators (KPIs) to drive continuous improvement in product quality and operational efficiency.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs and other Quality functions, to ensure quality requirements are effectively communicated and incorporated into product design, development, and manufacturing processes.
• Support external audits and inspections conducted by regulatory authorities or third-party organizations.
• Facilitate investigations and resolution of product quality issues, non-conformances, and customer complaints, participating in corrective and preventive actions (CAPAs) as necessary.
• Monitor and analyze quality data, trends, and metrics to identify areas for improvement and proactively address potential quality risks.
• Stay updated on industry regulations, standards, and best practices, ensuring compliance with applicable quality and safety requirements.
• Collaborate with suppliers and contract manufacturers to ensure their adherence to quality standards and requirements.