Quality Engineer Technician Calibration Coordinator
Quality Engineer Technician Calibration Coordinator
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Salary Not Disclosed
1 Vacancy
Job Description
Location: 571 Silveron Blvd Flower Mound TX
Shift: Monday Friday day shift hours flexible
Summary:
The Quality Engineer Technician Calibration Coordinator will be responsible for managing the calibration program ensuring compliance with industry regulations and company standards. In this role you will track calibration schedules coordinate external calibration services maintain and update calibration procedures and support internal and external audits. You will also collaborate with New Product Development (NPD) teams to ensure the existing toolset remains compatible with future products as well as other tasks needed to support the business.
Additionally you will be assisting the Quality Engineering team in developing applying revising and maintaining quality standards for processing raw or returned materials and/or components into partially finished and/or finished products. Responsible to perform root cause product investigation and disposition product.
What You Will Do:
- Work as part of the Returns team to receive investigate and inspect incoming product.
- Maintain an accurate inventory of calibrated tools.
- Track and schedule calibrations using CERDAAC software & Agile database to ensure timely compliance.
- Coordinate with external calibration service providers and manage calibrationrelated documentation.
- Verify and maintain calibration and operation of all tools maintain equipment logs and complete maintenance reports accurately.
- Develop update and enforce calibration procedures to comply with ISO 13485:2016 FDA regulations and NIST traceability requirements.
- Serve as the primary point of contact for internal and external auditors regarding calibration program compliance.
- Serve as the primary point of contact for all fieldbased personnel regarding calibration program escalations.
- Collaborate with NPD teams to assess tool compatibility with new products and recommend necessary updates.
What You Need:
Required:
- High School Diploma or equivalent
- 3 years of experience in calibration quality systems or a similar role in the medical device or regulated industry
- Knowledge of ISO 13485 FDA regulations and NIST traceability requirements
- Experience with troubleshooting and repair fundamentals
- Ability to work with and inspect very small objects and/or tools and component parts
Preferred:
- Associate of Science in Engineering or Engineeringrelated discipline
- Quality Assurance training
Required Experience:
IC
Employment Type
Full-Time
