Quality Assurance Manager

Overview

We are seeking an experienced and skilled Quality Assurance Manager to lead our quality assurance team in ensuring compliance with regulatory requirements, industry standards, and company policies. The ideal candidate will have a strong working relationship with the FDA, a proven track record of implementing effective quality systems, and a deep understanding of quality principles and methodologies.

Responsibilities

• Develop, implement, and maintain comprehensive quality assurance strategies and procedures to ensure compliance with FDA regulations, industry standards, and company policies. • Lead and manage quality assurance teams, providing guidance, training, and mentorship to ensure effective quality system implementation and maintenance. • Collaborate with cross-functional teams, including manufacturing, engineering, and research and development, to identify and mitigate quality risks and ensure effective quality planning. • Manage and maintain quality metrics, including quality performance indicators, audit and inspection results, and customer feedback, and report to senior leadership on quality performance. • Foster a culture of quality excellence within the organization, promoting a proactive and preventative approach to quality management. • Develop and manage relationships with FDA representatives, ensuring effective communication and collaboration on quality-related matters. • Lead and manage audits and inspections, ensuring effective preparation, execution, and follow-up, and implementing corrective actions as needed.

Requirements

• 5+ years of experience in quality assurance, with a focus on FDA-regulated industries, such as pharmaceuticals, medical devices, or Food and beverages. • Strong working relationship with the FDA, with experience in audit and inspection management, and a deep understanding of FDA regulations and guidelines. • In-depth knowledge of quality systems, regulations, and industry standards, including GMP, ISO 13485, and 21 CFR. • Excellent leadership, communication, and problem-solving skills, with the ability to collaborate effectively with cross-functional teams.