Calibration Manager

Alcon

$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent experience required; advanced degrees preferred
  • 5 years of relevant experience in a regulated environment
  • 3 years of demonstrated leadership experience
  • Strong knowledge of calibration principles and metrology
  • Familiarity with quality standards like ISO 13485 and 21 CFR Part 820

Responsibilities

  • Lead and manage the site calibration program for all measuring and test equipment
  • Ensure 100% on-time calibration execution and adherence to intervals
  • Oversee use of Calibration Management Systems (CMS)
  • Partner with Quality Assurance and Engineering to align calibration strategies
  • Manage relationships with external calibration vendors
  • Lead out-of-tolerance investigations and corrective actions
  • Drive continuous improvement initiatives in calibration processes

Benefits

  • Opportunity to work in a highly regulated industry
  • Engagement in continuous improvement projects
  • Cross-functional collaboration with Quality Assurance and Engineering teams
  • Exposure to advanced calibration technologies and systems
  • Potential for professional development and leadership growth
Full Job Description
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 complianceAll 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 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 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 ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. 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