Quality System Support Specialist at Fathom Mfg in Round Rock, Texas

Job Description:

Company History:

Fathom is one of the largest digital manufacturing platforms offering on-demand manufacturing in North America. With more than 90 large-platform industrial-grade 3D printing machines and a national footprint with more than 500,000 square feet of manufacturing capacity across 10 facilities, Fathom seamlessly blends in-house capabilities across plastic and metal additive technologies, CNC machining, injection molding & tooling, urethane casting, sheet metal fabrication, and design and engineering.

With over 50 years of industry experience, Fathom is at the forefront of the industry 4.0 digital manufacturing revolution serving clients in the technology, defense, aerospace, medical, automotive and IOT sectors. Fathom’s extensive certifications include ISO 9001:2015, ISO 9001:2015 Design, ISO 13485:2016, AS9100:2016, NIST 800-171 and ITAR.

Quality System Support Specialist Position Summary:

The Quality Management System (QMS) Support Specialist plays a critical role in maintaining and ensuring the integrity of medical device data within a manufacturing environment. This position is responsible for reviewing, organizing, and ensuring the accuracy of key quality-related documentation, including device history records, nonconformance reports, customer complaints, and other essential records that support the QMS. The specialist will scan, store and in some cases manually enter data into the company’s database system.

Additionally, this role will assist the Quality Manager and other team members in the ongoing maintenance and revision of quality management procedures, work instructions, forms and other documents necessary to maintain compliance with ISO certifications and other regulatory standards. The ideal candidate will possess a keen eye for detail, and strong understanding of quality systems.

Quality System Support Specialist Responsibilities:

• Responsible for quality management system support for medical device data within a contract manufacturing environment.
• Document review of device history records, nonconformance reports, customer complaints and other documents or records required to support the quality management system.
• Once documentation has been reviewed and accepted it will be scanned and organized in a computer database system or in some cases may require manual data entry.
• Assist the Quality Manager and other Quality representatives in the maintenance of procedures, work instructions, forms, etc., relevant to a quality management system in compliance to ISO 13485, ISO 9001 and regulatory requirements.

Quality System Support Specialist Qualifications/Requirements:

• Experience within a quality management system or quality assurance, preferably within the medical device manufacturing industry.
• Strong attention to detail with a focus on accuracy within the documentation.
• Proficient in document management systems and databases.
• Strong analytical skills to interpret data and identify discrepancies.
• Understanding of quality control processes, nonconformance management, and root cause analysis.
• Knowledge of regulatory requirements for medical devices and experience in dealing with certified audits.
• Ability to proactively identify issues and recommend solutions to enhance quality processes.
• Strong organizational skills with the ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
• Maintain a regular and predictable work schedule.
• Experience with MS Office & Adobe
• HS Diploma or equivalent required

Hours: 8-5p.m. Monday - Friday

Equal Opportunity Employer/Veterans/Disabled

This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9.

PI254449148

Salary: