Calibration Manager

Alcon; Fort Worth (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Alcon is seeking a Manager, Field Service Operations to lead site calibration programs across measuring and test equipment. You will ensure regulatory compliance, manage calibration vendors, and drive continuous improvement within QA and regulatory frameworks.

You will collaborate with Quality Assurance, Engineering, and Manufacturing to align calibration strategies with operational needs, develop SOPs, and mentor teams on calibration practices and documentation.

Qualifications

• Bachelor's Degree or equivalent years of directly related experience.
• Fluent in English and strong documentation practices.
• 5+ years of relevant experience and 3+ years of leadership.

Responsibilities

• Lead site calibration program ensuring accuracy and regulatory compliance.
• Coordinate calibration and maintenance activities across teams.
• Manage external calibration vendors and CIM/CMMS systems.
• Develop SOPs, training, and continuous improvement initiatives.
• Support FDA/ISO audits and QMS integration.
• Drive cost reductions while maintaining quality.

Skills

Leadership

Project management

Regulatory compliance

Quality Assurance

Cross-functional collaboration

Calibrations

Metrology

CMS/CMMS

SOPs

QMS integration

Education

Bachelor's Degree or equivalent

Tools

CMS/CMMS (Blue Mountain)

GAGEtrak

SAP PM

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes. The Manager, Field Service Operations (Professional Path) is primarily responsible for leading individual projects within field service operations, focusing on service contract documentation, installations, service case management, preventive maintenance, inventory management, invoicing, and returns.

Specifics Include:

• Lead individual projects within field service operations, applying advanced knowledge to achieve objectives and enhance project performance and operational efficiency
• Manage service contract documentation, new and demo installations, service case management, preventive maintenance, retro-fit activities, spare part and inventory management, invoicing, and returns
• Make operational decisions for projects, managing resources and schedules, and aligning activities with departmental objectives
• Oversee and coordinate teams, ensuring efficient task completion, adherence to processes, and supporting team performance and operational efficiency
• Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
• Meet individual job requirements and contribute to the overall compliance of the organization, committing to continuous improvement and regulatory compliance

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

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.

Key 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)

What you can bring to Alcon:

• Bachelor's Degree orEquivalent 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

Experience (Preferred)

• Demonstrated experience in Quality Assurance (QA) within a regulated environment (required)
• Experience in medical device, pharmaceutical, or other highly regulated industries strongly preferred
• Proven experience managing or leading calibration programs or teams

Technical Skills

• 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

Core Competencies

• 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

Key Performance Indicators (KPIs)

• On-time calibration completion rate
• Reduction in out-of-tolerance incidents
• Audit findings and overall compliance performance
• Equipment downtime related to calibration
• Data integrity and documentation accuracy
• Cost and efficiency improvements in calibration operations

Working Conditions & Physical Requirements

• Work environment includes both office and manufacturing floor settings
• Ability to lift up to 50 pounds unassisted
• May work in controlled environments (cleanroom, laboratory)
• Travel may be required for vendor management, audits, or training
• Must meet requirements to operate a company vehicle, including a valid driver's license

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.