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Bürkert Fluid Control Systems

Senior Lead - Quality Assurance/Quality Control - Metrology

Bürkert Fluid Control Systems, Huntersville, North Carolina, United States, 28078

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Where would you like to shape the success of your future career: At a worldwide leading manufacturer of process measuring and control technology? In a family- owned company that values its more than 3,700 employees in more than 30 countries and sees them all as individuals? In a team that breaks new ground with courage and passion? Did you answer "Yes" three times? Then it is time for us to make your acquaintance. RESPONSIBILITIES:Position Summary:The Senior Leader QA/QC is responsible for directing and overseeing the quality assurance and quality control functions across the organization to ensure compliance with applicable regulatory requirements (e.g. FDA, cGMP, ISO 9001). This role ensures that all products meet the highest quality standards before they reach the market and drives a culture of continuous improvement in quality systems and manufacturing operations.Key Responsibilities:Lead and manage QA/QC departments, including Quality Systems, Quality Control Laboratories, Document Control, and Compliance.Develop, implement, and maintain robust quality management systems in alignment with regulatory standards (cGMP, ISO 9001, FDA, cGMP).Ensure compliance with all relevant regulatory requirements and serve as the point of contact for audits and inspections (e.g., FDA, USDA, ISO certifying bodies).Drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.Oversee product release, change control, CAPA (Corrective and Preventive Actions), and deviation management.Lead internal audits and supplier qualification programs; manage external audit readiness and responses.Collaborate with cross-functional departments including R&D, Manufacturing, Supply Chain, and Regulatory Affairs to ensure quality objectives are integrated throughout the product lifecycle.Hire, train, and mentor QA/QC personnel; build high-performing teams.Monitor key quality metrics and report to executive leadership.Stay current on industry trends, emerging regulations, and best practices.Support Change Management TeamDrive/Support Sustainability within QA/QCParticipate in Safety Council with cross-functional teamDevelop Lab and Metrology methodologyCollaborate with Manufacturing/Assembly and align on continuous improvement of manufacturing processes (welding, machining, assembly, injection molding)REQUIREMENTS:Qualifications:Bachelor's or Master's degree in Life Sciences, Food Science, Chemistry, Engineering, or a related field.10+ years of progressive experience in QA/QC roles in Biopharma, Food & Beverage, or related regulated industry.5+ years in a leadership roleStrong knowledge of regulatory requirements (FDA, cGMP, ISO standards).Experience with laboratory operations, microbiological and chemical testing, and analytical method validation.Demonstrated success in leading regulatory inspections and audits.Demonstrated expertise within Metrology (CMM programming, Statistical Analysis)Excellent leadership, communication, and organizational skills.Lean Six Sigma or other continuous improvement certification is a plus.Preferred Skills:Prior experience in both Biopharmaceutical and Food & Beverage industries.Knowledge of digital QMS platformsSAP literacyAbility to manage QA/QC function and drive global initiatives.In return, we offer you exciting and challenging responsibilities, diverse perspectives with a high degree of individual freedom and a corporate culture that encourages you to use it.Curious? Then we look forward to receiving your application.