Calibration Manager

Alcon•Fort Worth, TX

3d•Hybrid

About The Position

The Tool Calibration Manager is responsible for leading, managing, and continuously improving the site-wide calibration program for all measuring and test equipment (M&TE). This role ensures full compliance with regulatory requirements, quality standards, and internal procedures while driving operational excellence, minimizing downtime, and supporting product quality. The Manager will provide leadership over calibration processes, systems, personnel (if applicable), and vendor relationships, while serving as a key stakeholder in Quality Assurance and regulatory compliance initiatives.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr)
The ability to fluently read, write, understand, and communicate in English
5 Years of Relevant Experience
3 Years of Demonstrated Leadership
Demonstrated experience in Quality Assurance (QA) within a regulated environment
Advanced knowledge of calibration principles, metrology, and measurement systems
Strong understanding of regulatory standards, including: ISO 13485, 21 CFR Part 820, ISO/IEC 17025
Hands-on experience with calibration management systems (CMS/CMMS)
Ability to interpret engineering drawings, specifications, and tolerances
Strong proficiency in Microsoft Office (especially Excel) and digital systems
Strong leadership and cross-functional collaboration skills
Excellent problem-solving and investigative capabilities
High level of attention to detail and data accuracy
Strong communication and stakeholder management skills
Ability to manage multiple priorities in a fast-paced, regulated environment
Deep commitment to quality, compliance, and continuous improvement

Nice To Haves

Experience in medical device, pharmaceutical, or other highly regulated industries strongly preferred
Proven experience managing or leading calibration programs or teams

Responsibilities

Lead and manage the site calibration program, ensuring all equipment meets accuracy and compliance requirements
Ensure 100% on-time calibration execution and adherence to defined calibration intervals
Oversee and optimize the use of Calibration Management Systems (CMS/CMMS) (e.g., Blue Mountain, GAGEtrak, SAP PM)
Partner with Quality Assurance, Engineering, and Manufacturing to align calibration strategies with operational needs
Manage relationships with external calibration vendors, including selection, performance monitoring, and cost control
Review, approve, and ensure compliance of all calibration certificates and records
Ensure traceability of all standards to NIST or equivalent governing bodies
Lead out-of-tolerance (OOT) investigations, including impact assessments, root cause analysis, and corrective/preventive actions (CAPA)
Own and maintain audit readiness, supporting FDA, ISO, and customer audits
Develop and implement standard operating procedures (SOPs), work instructions, and best practices
Drive continuous improvement initiatives, including process optimization and cost reduction
Provide technical leadership and training on calibration practices, compliance expectations, and equipment handling
Identify and implement alternative calibration strategies when standard methods are not applicable
Collaborate with QA to ensure full integration of calibration activities into the Quality Management System (QMS)