Metrology and Instrument Specialist

Job Responsibilities:

Instrument Management:

• Oversee the installation, calibration, and qualification of Coordinate Measuring Machines (CMM) and other equipment, ensuring compliance with Quality Management System standards, regulatory requirements, and cGMP.
• Develop, review, and approve internal protocols and reports related to instrument qualification/calibration, as well as evaluate and approve third-party protocols and reports.
• Create and review risk assessments for instrument calibration and qualification processes.
• Serve as the primary technical point of contact and manage relationships with instrument suppliers and external calibration service providers.
• Work with cross-functional teams to investigate deviations, OOS results, and customer complaints, implementing corrective and preventive actions (CAPA) to enhance instrument performance and product quality.
• Track and report key quality metrics related to the instrument management program.
• Identify opportunities for improvement and implement solutions to optimize instrument performance and quality control.
• Provide training on the proper use of instruments, metrology standards, GD&T, SPC, and new inspection techniques to quality team members.
• Develop and maintain QMS documents, such as operating manuals, for the proper use, maintenance, and cleaning of instruments.
• Ensure the instrument management program is consistently inspection-ready, with a focus on accurate documentation.
• Offer expert technical support in metrology, instrumentation, and measurement methods, acting as the main contact for manufacturing, quality, and other departments on-site.

Project Management and Technical Support:

• Lead projects aimed at improving product and process quality, including the implementation of new process control methods and advanced instrument technologies.
• Provide technical assistance in new projects, collaborating with Operations, Quality Control, Process Engineering, and Quality Engineering to define processes and select instruments that ensure product quality and reliability.
• Define user requirements specifications for new instruments.
• Design, review, and execute studies that support equipment and instrument qualification, as well as method validation.
• Participate in inspections and audits, supplying relevant information and addressing inspector/customer requests related to instrument management.
• Attend customer technical meetings to provide technical expertise on metrology and ensure customer requirements are met.

Qualifications:

• 3-5 years of experience in Quality Assurance, Quality Control, Quality Engineering, or Process Engineering in a manufacturing environment.
• Bachelor's degree in a technical field (e.g., Engineering, Materials Science, Data Analytics, Statistics) or equivalent work experience.