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Quality Assurance Director
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Confidential
Lewisburg, PA (In Person)
$77,500 Salary, Full-Time
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Job Description
Overview We are seeking a dynamic and highly experienced Quality Assurance Director to lead our quality management initiatives across manufacturing and product development operations. This pivotal role drives the development, implementation, and continuous improvement of comprehensive quality systems that ensure our products meet the highest standards of safety, efficacy, and compliance. As a key leader, you will champion a culture of quality excellence, oversee regulatory adherence, and foster collaboration across teams to deliver superior products that delight customers worldwide. Your energetic leadership will inspire teams to uphold rigorous quality controls while embracing innovation and operational efficiency. Duties Develop and execute strategic quality assurance plans aligned with industry standards, FDA regulations, HACCP (Hazard Analysis Critical Control Point), and CGMP (Current Good Manufacturing Practices). Lead and coordinate comprehensive quality audits to assess compliance with internal policies and external regulatory requirements, identifying areas for improvement. Oversee the design, implementation, and maintenance of robust quality systems that support manufacturing excellence and product integrity. Manage quality control processes including inspection, testing, and validation activities to ensure products meet specified standards before release. Drive continuous improvement initiatives by analyzing quality data, investigating root causes of defects or non-conformities, and implementing corrective actions. Collaborate with cross-functional teams—manufacturing, R&D, supply chain—to integrate quality assurance into all stages of product lifecycle development. Lead training programs to elevate team awareness of quality standards, regulatory updates, and best practices in QA/QC procedures. Conduct regular analysis skills assessments to enhance team capabilities in problem-solving and decision-making related to quality issues. Qualifications Proven experience in leading Quality Assurance functions within manufacturing environments, preferably in regulated industries such as medical devices or pharmaceuticals. Deep knowledge of