Sr Quality Technician - Metrologist

Bürkert Group; Huntersville (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Bürkert Group is seeking a Sr Quality Technician - Metrologist to lead QA/QC initiatives, manage laboratories and oversee metrology programs in a regulated environment. The role requires deep regulatory knowledge and strong leadership to drive quality across product lifecycles.

Responsibilities include leading audits, CAPA, change control and supplier qualification, as well as mentoring QA/QC personnel and collaborating with R&D, Manufacturing, and Regulatory Affairs to sustain compliance and

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Chemistry or related field.
• 10+ years progressive QA/QC experience in regulated industry (biopharma/food/beverage).
• 5+ years in a leadership role overseeing QA/QC.
• Strong knowledge of FDA, cGMP, ISO standards.

Responsibilities

• Lead and manage QA/QC departments including Quality Systems and Documentation.
• Develop and maintain QMS aligned with regulatory standards (cGMP, ISO 9001, FDA).
• Oversee audits and inspections (FDA, USDA, ISO certifying bodies).
• Drive continuous improvement to improve quality and efficiency.
• Oversee product release, change control, CAPA, deviation management.
• Lead internal audits and supplier qualification programs.
• Collaborate with R&D, Manufacturing, Supply Chain and Regulatory Affairs.
• Mentor QA/QC staff and monitor key quality metrics.

Skills

Leadership

Quality management

Auditing

Regulatory knowledge

Metrology

Analytical thinking

Communication

Continuous improvement

Education

Bachelor’s or Master’s in Life Sciences/Engineering

Tools

CMM programming

Statistical Analysis

Job description

## Sr Quality Technician - MetrologistApplylocations: Huntersvilletime type: Full timeposted on: Posted Yesterdayjob requisition id: JR\_00001279**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 methodologyCollaborate with Manufacturing/Assembly and align on continuous improvementREQUIREMENTS:* 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.**