Sr Quality Technician - Metrologist
About the Role
Join a worldwide leading manufacturer of process measuring and control technology, a family-owned company that values its more than 3,700 employees across more than 30 countries. We are seeking a Senior Quality Technician - Metrologist to lead and manage QA/QC departments, including Quality Systems, Quality Control Laboratories, Document Control, and Compliance.
Responsibilities
- 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.
Culture
Burkert USA Corp is a manufacturing and sales organization that is family-owned and was established in the US in 1984. Burkert employees enjoy an inclusive environment that's open to ideas and innovation for a growing company with opportunities for development. Work life balance is considered a priority with a comprehensive benefits package in place to support your personal and professional life.