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Senior Metrology Analyst

2 months ago

Salt Lake, Utah, United States ICU Medical Full time
FLSA Status: Exempt

Position Overview

Oversee and enhance the Metrology operations within the organization, focusing on the design, assessment, development, execution, and upkeep of measurement programs to ensure compliance with all cGMP standards.

Support validation and production processes by leveraging measurement science, mathematics, and physics to create, document, and sustain measurement systems, procedures, and methodologies for various inspection and testing equipment.

Evaluate innovative measurement techniques and methodologies, employing statistical approaches to assess measurement standards and processes.

This role necessitates a comprehensive understanding of the components within a medical device Quality Management System (QMS) as well as manufacturing and quality control procedures.

The ideal candidate will possess strong communication and leadership capabilities.


Key Responsibilities
  • Engage in the design, assessment, execution, and implementation of protocols in alignment with IQ/OQ/PQ/TMV requirements pertinent to quality control and assurance manufacturing activities.
  • Deliver hands-on technical guidance for establishing and defining accurate measurement techniques across various systems.
  • Create measurement testing methods, standard operating procedures (SOPs), and comprehensive reports.
  • Provide technical training to ensure all personnel comply with measurement protocols and cGMP standards, adhering to FDA regulations.
  • Prepare essential documentation, including user requirement specifications, test plans, and user manuals for instrumentation.
  • Assist in interpreting and selecting measurement and calibration solutions that meet required accuracy levels.
  • Demonstrate proficiency with advanced measurement tools.
  • Conduct Data Integrity/System Audit Trail Review functions for instrumentation and perform internal audits of Metrology documentation.
  • Participate in vendor, client, internal, and regulatory audits, generating necessary documentation.
  • Execute all quality assurance and validation tasks in accordance with applicable guidelines.
  • Initiate problem-solving and technical decision-making appropriate to experience level.
  • Exhibit written and verbal communication skills suitable for interaction with staff, vendors, and clients.
  • Direct, plan, design, and coordinate project development activities.
  • Provide technical expertise across all project endeavors and engage in strategic planning.
  • Perform additional functions as required or assigned.
  • Contribute to special projects as they arise.

Qualifications and Skills
  • Thorough understanding of FDA and cGMP regulations.
  • Working knowledge of laboratory instrumentation and equipment.
  • Familiarity with systems utilized in the Medical Device sector.
  • Expertise in Measurement System Analysis (MSA) methodologies.
  • Proficiency in Geometric Dimensioning & Tolerancing (GD&T).
  • Experience in designing and developing measurement tools and fixtures.
  • Familiarity with CAD software (preferably Solid Works) and 3D printing software.
  • Ability to provide training to others.
  • Strong analytical and critical thinking skills.
  • Effective troubleshooting abilities.
  • Excellent communication skills with vendors and staff at all levels.
  • Capacity to work collaboratively within a team environment.
  • Experience in writing, reviewing, and approving quality documents.
  • Ability to prioritize tasks and manage conflicting priorities effectively.

Education and Experience
  • Minimum age of 18 years.
  • Bachelor's Degree in Engineering or Science preferred; equivalent experience or vocational qualifications may be considered.
  • 4+ years of relevant experience providing the necessary knowledge, skills, and abilities for the role.
  • Prior experience in a medical device manufacturing environment is preferred, along with certifications from ASQ.
  • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).

Physical Requirements and Work Environment
  • Regularly required to communicate effectively.
  • Must be able to lift at least 25 lbs, with the potential to lift up to 50 lbs.
  • Ability to sit or stand for extended periods and view computer screens.
  • Potential travel of 10-20% may be required.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.