Sr Quality Technician - Metrologist

Burkert GmbH

  • Huntersville, NC
  • 2 days ago
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    Skills

    • Analytical Method Validationunmatched
    • Auditingunmatched
    • Best Practicesunmatched
    • Biologyunmatched
    • Capability Maturity Model (CMM)unmatched
    • Change Controlunmatched
    • Change Managementunmatched
    • Chemistryunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Customer Satisfactionunmatched
    • Document Controlunmatched
    • External Auditunmatched
    • FDA (Food and Drug Administration)unmatched
    • FDA Requirementsunmatched
    • Food Scienceunmatched
    • Food and Beverage Industryunmatched
    • ISO (International Organization for Standardization)unmatched
    • ISO 9001unmatched
    • Industry/Trade Analysisunmatched
    • Internal Auditunmatched
    • Laboratoryunmatched
    • Laboratory Managementunmatched
    • Laboratory Operationsunmatched
    • Laboratory Techniquesunmatched
    • Leadershipunmatched
    • Lean Six Sigmaunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Assemblyunmatched
    • Mentoringunmatched
    • Metrologyunmatched
    • Microbiologyunmatched
    • Organizational Skillsunmatched
    • Process Improvementunmatched
    • Product Lifecycleunmatched
    • Product Programsunmatched
    • Quality Assuranceunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Quality Monitoringunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Statistical Analysis System (SAS)unmatched
    • Statistical Programming Languagesunmatched
    • Supply Chainunmatched
    • Sustainabilityunmatched
    • Trend Analysisunmatched
    • United States Department of Agriculture (USDA)unmatched
    • Vendor/Supplier Evaluationunmatched

    Description

    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:

    • 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).
    • 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 Team
    • Drive/Support Sustainability within QA/QC
    • Participate in Safety Council with cross-functional team
    • Develop Lab and Metrology methodology

    Collaborate with Manufacturing/Assembly and align on continuous improvement

    REQUIREMENTS:

    • 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 role
    • Strong 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.

    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.

    Numbers & Facts

    LocationHuntersville, NC

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