Job Description

🌟 Exciting Opportunity at Ellab - Join Our Team! 🌟

We're seeking a Calibration Lead/Project Manager to join our vibrant team and embark on an exciting journey with us.

As an industry frontrunner, Ellab is committed to providing cutting-edge benefits that make us stand out. Join us and enjoy:

Benefits

🏖️ Time to Unwind:

• Kick off your journey with 2 weeks of vacation (3 weeks at your 5yr. & 4 weeks at your 10yr. anniversaries)
• Stay healthy with 2 weeks of sick time
• Celebrate with 10 Company Holidays
• Experience a rejuvenating 1-week winter shutdown

💼 Financial Well-being:

• Invest in your future with a 401(k) match of $1 for $1 up to 4%

👨‍👩‍👧‍👦 Health and Family First:

• Embrace worry-free living with fully paid family medical insurance
• Take care of your pearly whites, vision, and more with dental, vision, life, and disability insurance available
• 6 weeks of parental leave

Job Brief

The as a Calibration Lead the role is responsible for making sure that customer equipment is calibrated correctly and giving accurate readings. As a Project Manager the role shall perform managerial consulting services in conjunction with execution, data analysis and reporting, and calibration.

The position will primarily work during normal business hours of 8 AM to 5 PM, Monday through Friday, but may require occasional off-hours and weekend work, and travel.

The goal of the Calibration Lead/Project Manager is to meet all customer expectations while performing field support of customer equipment and manager the day to day responsibilities of the field team.

Responsibilities

The Calibration Lead/Project Manager is responsible for:

• Following the organization’s field calibration program when onsite and following all customer, internal, ISO 9001 and GMP requirements
• Performing calibrations and verifications for field calibration projects
• Interfacing with customers to develop interval and tolerances, scheduling, and communicating calibration results
• Tracking and communicating project statuses for field calibration projects
• Maintaining knowledge on standards, regulations, issues, and news with respect to calibration
• Recording and reconciling project costs and information required for final billing
• Analyzing and interpreting data from calibration results if it meets equipment tolerances
• Troubleshooting customer and Ellab equipment
• Supporting and maintaining the field calibration department equipment inventory
• Ensuring adequate resources (Ellab Team, hardware, software, supplies) are available to satisfy all the requirements of the project
• Guiding Ellab Calibration Specialists on daily priorities
• Ensuring all Ellab Team are compliant with customer site access, training, SOPs, GDP, and data integrity
• Creating and updating various tools required to adequately manage the project throughout the project lifecycle (Microsoft Excel, Microsoft Project, Microsoft Visio, etc.)
• Collaborating with customer Teams including Project Managers, Senior Leadership, and Internal Department leads to align on deliverable expectations, timelines, and problem resolution
• Setting up and facilitating meetings between Ellab and customers, as needed, to ensure smooth progression throughout the process lifecycle
• Creating and distributing metrics showing the project’s status and KPIs
• Escalating issues and concerns timely to the appropriate customer Senior Leadership/Escalation Team
• Acting as a liaison between Ellab and customer to handle all changes in scope throughout the project

Requirements

• At least 8 years previous technical experience or CCT certification from ASQ
• BS in Engineering, Computer Science, or technical experience
• Experience in an FDA-regulated industry, preferably in an engineering, validation, or operations role
• Excellent communication and problem-solving skills
• Computer literacy, including proficiency with Ellab software applications
• Knowledge of measurement principles: measurement uncertainty, measurement traceability, measurement standards, test uncertainty, calibration intervals, and out-of-tolerance reporting
• Familiar with these regulations: FDA 21 CFR Part 820 and 210, ISO 13485, and ISO 17025
• Must be able to lift 50 lbs

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