Calibration Specialist

Title: Calibration Specialist

Department: Quality 

Reports to: Quality Control Manager

Location: Onsite, Marquette, MI

The Calibration Specialist is responsible for developing, managing, and continuously improving the company’s calibration program to ensure the accuracy, reliability, and compliance of all measuring and test equipment. This role provides technical expertise in calibration methods, measurement uncertainty, and regulatory requirements, while leading initiatives to optimize calibration processes. The Calibration Engineer oversees the company’s complete calibration system using GAGEtrak software, ensuring that both internally calibrated equipment and vendor-serviced instruments are maintained, tracked, and documented in alignment with ISO, FDA, and other applicable industry standards. This position is critical in helping EXALTA maximize the number of patients served while maintaining a high level of quality and safety. 

• →Design, implement, and maintain a comprehensive calibration program that supports regulatory compliance (e.g., ISO 13485, FDA) and aligns with company quality objectives.
• →Serve as the subject matter expert (SME) on calibration, providing technical guidance on measurement uncertainty, traceability, and best practices to cross-functional teams.
• →Manage and optimize the calibration system in GAGEtrak, ensuring accurate data entry, scheduling, reporting, and system integrity.
• →Perform and oversee complex calibrations on electrical, mechanical, dimensional, and pressure instruments, ensuring precision and reliability.
• →Develop, validate, and maintain calibration procedures and work instructions in accordance with industry standards and regulatory requirements.
• →Lead vendor management for outsourced calibration services, including supplier qualification, certification reviews, and performance monitoring.
• →Analyze calibration data and trends to identify risks, drive corrective actions, and implement process improvements to enhance measurement accuracy and reduce downtime.
• →Support equipment selection, qualification, and validation activities by advising on calibration requirements and standards.
• →Collaborate with engineering, production, and quality teams to resolve technical issues, prevent measurement errors, and improve equipment reliability.
• →Prepare for and actively support internal and external audits, providing calibration records, documentation, and technical expertise.
• →Provide training and mentorship to technicians and other staff involved in calibration-related activities.
• →*This is not an exhaustive list of duties or functions and may not necessarily comprise all of the essential functions.* 

• Bachelor’s degree in Biomedical or Mechanical Engineering, Engineering Technology, or relevant Engineering discipline (preferably from an ABET accredited program) is preferred or relevant years of experience in lieu of a degree
• 2+years of progressive experience in medical device manufacturing or related field, such as aerospace or life sciences

• Fundamental knowledge in spine and orthopedic medical device technologies 
• Deep knowledge of calibration principles, metrology, measurement uncertainty, and traceability.
• Strong understanding of manufacturing, regulatory and quality requirements in a highly regulated environment (ISO 13485, ISO 17025, FDA, or equivalent).
• Ability to develop and validate calibration methods and procedures.
• Proficiency with calibration management software (GAGEtrak preferred) and calibration equipment.
• Strong analytical, problem-solving, and root-cause investigation skills.
• Excellent technical writing and documentation abilities.

• Exceptional attention to detail and organizational skills.
• Effective communication and interpersonal skills with the ability to influence and collaborate across teams.
• Strong sense of ownership and accountability for compliance and accuracy.
• Ability to manage multiple priorities in a fast-paced environment.
• Continuous improvement mindset, with initiative to drive process enhancements.
• Ability to mentor and train others, fostering knowledge sharing and skill development.