Sr. Quality Manager

The Quality Manager is responsible for establishing, leading, and maintaining a robust Quality Management System (QMS) to ensure all medical devices manufactured at the site meet applicable regulatory, safety, and quality requirements. This role serves as the primary quality authority for the facility and acts as the site representative to regulatory agencies and notified bodies. The position plays a critical role in supporting compliance, operational excellence, and continuous improvement as the organization builds and scales a new manufacturing facility. The Quality Manager is tasked with ensuring that all medical devices manufactured at our facility meet the highest standards of quality and safety. This role involves overseeing quality management systems to ensure compliance with FDA regulations, ISO standards, and other health authority standards. Key Responsibilities: Quality Management System & Regulatory Compliance Establish, implement, and maintain an effective Quality Management System compliant with ISO standards, FDA regulations, MDSAP, and other applicable health authority requirements. Serve as the site Quality Management Representative for FDA inspections and Health Authority audits. Ensure ongoing compliance with global regulatory and industry standards, including GMP and medical device regulations. Prepare, review, and approve quality-related SOPs, work instructions, and controlled documentation. Maintain quality certifications and manage quality-related risks. Audits & Inspections Plan, conduct, and lead internal quality audits. Coordinate and support external audits, certification audits, customer audits, and regulatory inspections. Review audit findings, ensure timely corrective actions, and monitor effectiveness. Validation, Qualification & Change Control Lead and participate in qualification and validation activities (IQ/OQ/PQ). Develop, maintain, and execute the Validation Master Plan (VMP). Define quality requirements for equipment, process, and system validations. Coordinate and manage change control activities in collaboration with crossu2011functional teams. Quality Assurance & Quality Control Oversee incoming inspection, inu2011process controls, and final product verification activities. Establish quality control procedures, sampling plans, and inspection criteria. Review and approve QC test results and quality records. Manage calibration programs for inspection and test equipment. Implement and maintain environmental monitoring and product stability programs. Monitor quality metrics, trends, and KPIs to drive datau2011driven decision making. Implement SPC and other quality tools in collaboration with manufacturing. Nonconformance, CAPA & Continuous Improvement Lead investigations related to nonconformities, deviations, complaints, and vigilance activities. Perform root cause analysis and drive effective corrective and preventive actions (CAPA). Manage nonconformance reporting and resolution processes. Identify opportunities for process optimization and continuous improvement. Facilitate crossu2011functional quality improvement initiatives and teams. Supplier & Customer Quality Manage supplier qualification and supplier quality performance. Conduct supplier audits and review supplier corrective actions. Handle customer quality issues, complaints, and quality documentation requests. Support product certification requirements and coordination with regulatory bodies as needed. Lead product recall activities, when required, in coordination with the Legal Manufacturer. Leadership & People Management Lead, coach, and develop the Quality Assurance and Quality Control teams, including technicians and inspectors. Deliver quality training programs, including GMP and regulatory compliance. Conduct performance evaluations and support professional development planning. Foster a strong quality culture across the organization. Required: Minimum of 8 years of experience in a quality leadership role, preferably within the medical device industry. Strong knowledge of ISO standards, FDA and Canadian regulations, CFR 21 Part 820, and GMP requirements. Demonstrated experience with validation, audits, CAPA, SPC, and quality system implementation. Excellent leadership, communication, and crossu2011functional collaboration skills. Strong project management, analytical, and problemu2011solving abilities. Job Type & Location This is a Permanent position based out of Fort Worth, TX. Pay and Benefits The pay range for this position is $145000.00 - $160000.00/yr. Full benefits, discretionary bonus, dental, medical, 401K Workplace Type This is a fully onsite position in Fort Worth,TX. Application Deadline This position is anticipated to close on Apr 9, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-03-30