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2 results for Quality Assurance in Plano, TX

Quality Assurance Manager

Dallas, TX
onsite
Permanent / Full Time
110000 - 120000 USD / Yearly
We are looking for a Quality Assurance Manager to lead quality programs for a manufacturing operation in Dallas, Texas. This role will oversee quality systems, guide audit readiness, and strengthen compliance practices across the facility while partnering with cross-functional teams to improve product performance and process consistency. The ideal candidate brings strong leadership, hands-on knowledge of recognized quality standards, and the ability to drive continuous improvement through practical, data-informed decision-making. Responsibilities: • Lead the quality function by supervising technicians and related staff, setting priorities, and ensuring daily activities support production and customer expectations. • Establish annual quality objectives that support broader business priorities and translate them into measurable departmental plans. • Administer and sustain certification efforts for key management standards, including ISO 9001, ISO 14001, and ISO 18001, while maintaining compliance with documented quality processes. • Deliver training and guidance that helps employees understand quality procedures, system requirements, and their role in maintaining standards. • Direct investigations related to customer complaints, warranty concerns, returns, and internal nonconformances, ensuring corrective and preventive actions are completed effectively. • Partner with teams across the organization to create, refine, and maintain process documentation, operating procedures, and quality records. • Plan and conduct internal audits, document findings, close out observations, and prepare the organization for external audits and certification reviews. • Develop and monitor supplier quality performance metrics, collaborate with purchasing on scorecards, and build strong working relationships with suppliers to improve results. • Support new product launches and product modifications by confirming that required quality characteristics, controls, and compliance expectations are met. • Provide quality-focused direction to production operations while reinforcing safe, efficient, and consistent manufacturing practices.
2026-04-28T00:00:00Z

Quality Director

Dallas, TX
onsite
Permanent / Full Time
150000 - 160000 USD / Yearly
We are looking for an experienced Quality Director to lead and manage the Quality Unit in a sterile drug manufacturing environment. This role involves ensuring compliance with regulatory standards, overseeing quality operations, and serving as the primary expert in aseptic manufacturing and pharmaceutical distribution. The ideal candidate will bring strategic leadership and technical expertise to maintain high-quality standards and regulatory adherence. Responsibilities: • Lead the Quality Unit to ensure compliance with all regulatory standards for 503B Outsourcing Facilities and sterile drug manufacturing. • Oversee quality operations, including aseptic manufacturing processes and wholesale pharmaceutical distribution. • Represent the organization during audits and inspections conducted by regulatory agencies and third-party auditors. • Manage documentation processes, including batch records, ensuring compliance with cGMP and aseptic protocols. • Develop and implement quality systems for deviation management, change control, investigations, and product recalls. • Approve validation protocols, qualification reports, and standard operating procedures to meet regulatory requirements. • Ensure adherence to guidelines for handling hazardous drugs and sterile preparations. • Maintain compliance with state and federal regulations governing wholesale drug distribution. • Drive continuous quality improvement initiatives and risk management strategies. • Provide technical expertise and leadership in sterile manufacturing and quality assurance practices.
2026-04-17T00:00:00Z