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Metrology Operations Specialist

2 months ago

Austin, Texas, United States ICU Medical Full time

FLSA Status: Exempt

Position Overview
Oversee and facilitate ICU Metrology functions, ensuring the design, development, implementation, and maintenance of measurement programs comply with all cGMP standards. This role is pivotal in supporting validation and manufacturing processes by applying principles of measurement science, mathematics, and physics to create, document, and uphold measurement systems, procedures, and methodologies for various inspection and testing equipment.

Key Responsibilities

• Engage in the design and review processes, executing and implementing protocols that adhere to IQ/OQ/PQ/TMV requirements related to quality assurance and manufacturing activities.

• Deliver hands-on technical assistance in establishing and defining appropriate measurement techniques across various systems within the organization.

• Formulate measurement testing methods, standard operating procedures (SOPs), and comprehensive reports.

• Provide technical training to ensure all personnel comply with measurement protocols and cGMP standards in alignment with FDA regulations.

• Prepare essential documentation, including user requirement specifications, test plans, and user manuals for instrumentation.

• Assist in selecting and interpreting measurement and calibration options to achieve the required accuracy.

• Demonstrate proficiency with advanced measurement tools.

• Conduct Data Integrity/System Audit Trail Reviews for instrumentation and perform internal audits of Metrology documentation.

• Participate in vendor, client, internal, and FDA audits, generating necessary documentation.

• Execute all quality assurance and validation activities in accordance with applicable guidelines, including FDA, GMP, and ICH standards.

• Initiate problem-solving and technical decision-making appropriate to experience level.

• Exhibit strong written and verbal communication skills for effective interaction with staff, vendors, and clients.

• Direct, plan, design, and coordinate development project activities, providing technical expertise throughout.

Knowledge, Skills & Qualifications

• In-depth understanding of FDA and cGMP regulations.

• Familiarity with laboratory instrumentation and equipment.

• Knowledge of systems utilized within the Medical Device sector.

• Proficient in Measurement System Analysis (MSA) methodologies.

• Expertise in Geometric Dimensioning & Tolerancing (GD&T).

• Experience in designing and developing measurement tools and fixtures.

• Proficient in CAD software (preferably Solid Works) and familiarity with 3D printing technologies.

• Strong training capabilities.

• Excellent analytical and critical thinking skills.

• Effective troubleshooting abilities.

• Strong communication skills with vendors and all levels of staff.

• Ability to work collaboratively in a team environment.

• Experience in writing, reviewing, and approving quality documents.

• Ability to prioritize tasks methodically and manage conflicting priorities.

Education and Experience

• Minimum age requirement: 18 years.

• Bachelor's Degree in Engineering or Science preferred; equivalent relevant academic or vocational qualifications or relevant experience may be considered.

• A minimum of 4 years of experience providing the necessary knowledge, skills, and abilities for the role, or an equivalent combination of education, training, and experience.

• Previous experience in a medical device manufacturing environment is preferred, along with certifications from ASQ.

• Proficiency in Microsoft Excel, Word, PowerPoint, and Outlook is required.

Physical Requirements and Work Environment

• Regularly required to communicate effectively.

• Ability to lift a minimum of 25 lbs, with potential to lift up to 50 lbs.

• Must be able to sit or stand for extended periods and view computer monitors for prolonged durations.

• Job may require travel up to 10-20% of the time.