Position Overview: 

The Calibration Technician plays a crucial role in maintaining the quality and compliance of equipment used in Outset Medical, following ISO 13485 and 21 CFR Part 820 standards. This individual contributor role is responsible for managing the calibration program for both Headquarters and the Field Service organization, performing preventive maintenance (PM) and calibration activities, coordinating with various stakeholders, and supporting quality management activities. The Calibration Technician will also manage equipment records and ensure calibration and preventive maintenance activities are conducted on time.

 

Maintain Calibration Program Perform Preventive Maintenance and Calibration Non-Conformance Management Coordination with Department Owners Equipment Process Ownership Update Equipment Records Support Other Quality Activities

 

Required Qualifications:

High school diploma or equivalent is required. An Associate’s degree in a technical field, or certification in Metrology, Calibration, or related field is preferred. Minimum of 3 years of experience in calibration, maintenance, or a related quality role in the medical device or similar regulated industry. Familiarity with ISO 13485, 21 CFR Part 820, and calibration standards in a regulated environment. Skills: Strong attention to detail and ability to follow standard operating procedures and documentation requirements. Excellent organizational and time management skills to handle multiple tasks and meet deadlines. Effective communication skills, with the ability to collaborate with different departments and external vendors. Basic computer skills, including proficiency with calibration management systems and Microsoft Office applications. Problem-solving skills to identify issues and follow the proper procedures for resolution.

 

Desired Qualifications:

Strong analytical and problem-solving skills. Focused, target driven with a positive, can-do attitude. Drive to assigned objectives which delivers best practice results, added value and continuous improvements across the business and quality management system. Effective communication and interpersonal skills, with the ability to interact with various stakeholders. Ability to lift equipment weighing up to 50 lbs and work in a lab environment. Must be able to work independently and as part of a team.