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Calibration & RMA Coordinator
2 months ago
Join a cutting-edge Medical Device company in the heart of Orange County as their next Calibration & RMA Coordinator on a contract basis In this key contract role, you will be ensuring top-notch equipment performance and regulatory compliance. You will take charge of the equipment calibration program and RMAs, while also playing a critical role in equipment qualification and re-qualification processes. You will collaborate closely with equipment owners and suppliers to troubleshoot and resolve issues, all while supporting vital equipment and process validations.
The Calibration & RMA Coordinator will also partner with the Product Development, Manufacturing, and Quality Control teams to ensure the highest standards of product quality and regulatory compliance. You'll be instrumental in driving initiatives related to ISO 13485, FDA regulations, CGMP, and Quality System Regulations, contributing to the company’s success in management reporting, production, and facility support. This role offers a unique opportunity to be involved in audits and impact the company’s compliance efforts. If you're ready to make a meaningful impact in a fast-paced, innovative environment, this is your chance
The Calibration & RMA Coordinator will:
- Monitor and maintain laboratory and engineering equipment to ensure preventive maintenance and calibration program compliance, including budgets and POs.
- Update equipment processes to ensure compliance with latest requirements and to streamline processes wherever possible.
- Review and understand quality regulations for audits, compliance, and implementation.
- Revise and format Quality System controlled documentation, including procedures, forms, and engineering documents.
- Support validations, perform testing, and update QA/QC/process documentation.
- Provide support in updating MVP and the associated documents.
- Co-Owner of DicksonOne system and all associated loggers.
- Co-Owner of XTrak system with USCalibration.
- Monitor and maintain the environmental monitoring program for the cleanrooms.
- Other administrative duties as required, including printing labels, maintaining logbooks, maintaining environmental logbooks, etc.
- Establish and maintain document control practices for the manufacturing area including batch records, data systems, and material release.
- Review test results and release material for use.
- Assist the Quality Assurance team with any ad hoc reports and assignments as required.
- Performs in-process, final, or incoming inspections as required.
- Review LDD Batch Records.
- Supports RMA-LDD.
- Write and review material review board dispositions within the functional area.
- Maintain working knowledge of all U.S. and International standards relating to medical devices including biocompatibility, physicochemical, optical mechanical, IEC/EMC, ISO, etc. for the company as required.
- Other responsibilities as defined by the Senior Quality Operations Manager.
Requirements:
- Bachelor's degree or a combination of education and experience.
- 1-2 years’ experience with Calibrations & RMAs in a FDA regulated environment.
- Knowledgeable of equipment and calibration of equipment.
- Microsoft Word; Microsoft Excel.
- QAD experience a plus.
- Training to be completed per the training plan for this position as maintained in the document control system.
- Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11.
- Knowledgeable of ISO 13485.
