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burkert·5 days ago

Sr Quality Technician - Metrologist

Huntersville, United States of AmericaMid · 5-8 yearsH1B likely

About this role

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.