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Job OverviewThe Senior Quality Manager is responsible for the administration, supervision, and development of the San Rafael Quality Assurance and Quality Engineering functions.The role involves actively building a high-performance culture and driving the growth and development of talent within the team.The role's purpose is to ensure full compliance with regulatory requirements such as 21 CFR 820, ISO ****, and other applicable standards.RDC ANVISAMHLW MO 169TG(MD) Sch3MDROther applicable regulations, including production and process controls.The Senior Quality Manager reports to the Global Head of Quality Operations, manages the business unit's quality management system, promotes a zero-defect culture, and delivers consistent and reliable operational performance.ResponsibilitiesEnsure Material Review Boards are in place to ensure products are appropriately dispositioned on schedule, with corrective and preventive actions initiated to meet regulatory requirements.Develop and implement systems to support development and production teams in quality planning, inspection techniques, sampling methods, statistical analysis, biological testing, and regulatory standards application.Develop and implement procedures to assure products for human use meet design and functional specifications, covering raw material delivery, device manufacturing, and documentation.Lead performance management, talent development, and team coaching.Support regulatory agency and customer quality audits.Ensure components and devices are checked in accordance with the Quality Management System before release.Assist and train associates in probability and statistics concepts.Perform failure appraisal and analysis, both internal and external.Place products or processes on hold when necessary.Design and develop forms and instructions for recording, evaluating, and reporting quality data.Manage the Corrective and Preventive Action program.Select and validate test equipment based on operational / quality requirements.Utilize formal problem-solving techniques to resolve product and / or process issues.Lead cross-functional teams to resolve product and / or process issues or objectives.Collaborate with suppliers to improve product quality and resolve quality issues.Ensure compliance with FDA QSR (21 CFR 820), ISO ****, RDC ANVISA, MHLW MO 169, TG(MD) Sch3 / MDD, and MDR Standards.Oversee quality control documentation, effectiveness reports, checklists, logs, and accuracy; assess results and provide recommendations.Lead corrective action requests and preventive measures within targeted budgets.Ensure product meets quality and efficiency standards, devise improvements, and produce high-quality goods.Develop product quality plans, statistical control monitoring, and drive process control initiatives to improve yield, quality, and reliability.Education & ExperienceDegree with a scientific or engineering emphasis.ASQ Certified Quality Engineer recommended; Six Sigma Green / BlackBelt recommended.Minimum of ten (10) years experience in a regulated environment.Experience includes senior level positions within medical device organizations.Proven experience leading teams in a manufacturing environment.Key Requirements & CompetenciesAnalytical, design, problem-solving, and project management skills.Technical proficiency and advanced statistical methodology application.Strong interpersonal, oral and written communication skills.Teamwork, judgment, motivation, planning, organization, professionalism, adaptability, dependability, and initiative.Excellent computer skills and high motivation with a sense of urgency.Strong coaching and mentoring abilities; building effective teams.Values : integrity, accountability, inclusion, teamwork, innovation.Supervisory ResponsibilitiesThis position supervises Quality Managers, Senior Quality Engineers, and Quality Engineers (directly or indirectly).TravelMay require up to 10% travel to TE sites and customer locations as needed.#J-*****-Ljbffr
