Quality System Support Specialist

1 week ago

Round Rock, United States Fathom Mfg Full time
Job DescriptionJob 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.



Compensation details: 20-25 Hourly Wage



PIa9c3287f615a-25405-35983280

  • Control Systems Specialist

    2 weeks ago

    Round Rock, Texas, United States Facility Solutions Group Full time

    Job Title: Control Systems SpecialistJob Summary: We are seeking a highly motivated Control Systems Specialist to support the development and deployment of scalable control systems. The ideal candidate will have a strong understanding of electronic components, commercial HVAC and lighting systems, and experience with BACnet, Modbus, and other common BAS...

  • IT Support Specialist

    4 weeks ago

    Round Rock, Texas, United States Alpha Paving Industries LLC Full time

    Job Title: IT Support SpecialistAlpha Paving Industries LLC is seeking a skilled IT Support Specialist to join our team. As the primary contact for technical support, you will be responsible for providing assistance with hardware and software issues, ensuring the smooth operation of computer systems, networks, and software...

  • Nurse Practitioner

    4 weeks ago

    Round Rock, United States Pain Specialist of America LLC Full time

    Pain Management Specialist Job DescriptionPain Specialists of America LLC is seeking a compassionate and skilled Nurse Practitioner to join our team. As a Pain Management Specialist, you will work closely with our dynamic team to provide high-quality patient care and support our multisite comprehensive pain management services.Key Responsibilities:Perform...

  • IT Support Specialist

    4 weeks ago

    Round Rock, United States Alpha Paving Industries LLC Full time

    IT Support SpecialistJob Locations US-TX-Round RockJob ID 2024-1451# of Openings 1Category Information TechnologyOverviewJob Purpose: Alpha Paving is the industry leader in construction, specializing in asphalt and concrete paving. We are seeking a dedicated and knowledgeable IT Support Specialist to join our team. The ideal candidate will be responsible...

  • Wound Care Specialist

    4 weeks ago

    Round Rock, United States Inova Health System Full time

    Job Title: Wound Care SpecialistBaylor Scott & White Health is seeking a highly skilled Wound Care Specialist to join our team in Round Rock, Texas.Job Summary:The Wound Care Specialist will be responsible for providing high-quality patient care, conducting detailed clinical assessments, and creating individualized care plans to promote wound healing and...

  • Pain Management Specialist

    3 weeks ago

    Round Rock, Texas, United States Pain Specialist of America LLC Full time

    Pain Management Specialist Job DescriptionWe are seeking a highly skilled and compassionate Pain Management Specialist to join our dynamic team at Pain Specialists of America LLC. As a key member of our team, you will be responsible for providing high-quality patient care and contributing to the development of effective pain management plans.Key...

  • Electrical Systems Specialist

    4 weeks ago

    Round Rock, United States Texas State Full time

    Job SummaryWe are seeking a highly skilled and experienced Electrical Systems Specialist to join our team at Texas State University. As an Electrical Systems Specialist, you will be responsible for performing journey-level electrical work, including installation, maintenance, and repair of campus electrical systems and equipment.Key ResponsibilitiesPerform...

  • IT Support Specialist

    3 weeks ago

    Round Rock, United States HDR Full time

    IT Support SpecialistAt HDR, we're committed to creating a workplace where every employee-owner feels valued, respected, and empowered to bring their authentic selves to work every day.We're looking for an IT Support Specialist who can help us achieve this vision by providing exceptional technical support and expertise to our staff.The ideal candidate will...

  • IT Support Specialist

    4 weeks ago

    Round Rock, Texas, United States HDR Full time

    Job SummaryAt HDR, we're seeking a skilled IT Support Specialist to join our team. As a key member of our IT department, you'll play a crucial role in ensuring the smooth operation of our technology infrastructure.Key ResponsibilitiesApply technical expertise to address business needs and constraintsAssist staff in achieving efficient and effective use of...

  • Medical Support Specialist

    1 month ago

    Round Rock, United States Ascension Full time

    Job SummaryWe are seeking a skilled Medical Support Specialist to join our team at Seton Medical Center Williamson. As a Medical Support Specialist, you will play a vital role in providing high-quality patient care and support to our patients and families.ResponsibilitiesAssist patients with daily living activities, such as bathing, dressing, and...

  • IT Support Specialist

    2 weeks ago

    Round Rock, Texas, United States HDR Full time

    At HDR, we're committed to creating a workplace where every employee-owner feels valued, respected, and empowered to bring their authentic selves to work every day.We're looking for an IT Support Specialist to join our team, someone who can apply technology to address business needs and constraints, assist staff in achieving efficient and effective use of...

  • Diagnostic Imaging Specialist

    3 weeks ago

    Round Rock, Texas, United States Healthcare Support Full time

    Healthcare Support is seeking a skilled Diagnostic Imaging Specialist to fill a 13-week travel assignment in Round Rock, Texas.Job RequirementsSpecialty: CT TechnologistDiscipline: Allied Health ProfessionalDuration: 13 weeks40 hours per weekShift: 10 hours, nightsEmployment Type: Travel2 years of experience required, Texas license, BLS, and ARRT...

  • Office Support Specialist

    4 weeks ago

    Round Rock, Texas, United States Metasys Technologies, Inc. Full time

    Job Title: Office Support SpecialistMetasys Technologies, Inc. is seeking a highly organized and detail-oriented Office Support Specialist to join our team. As an Office Support Specialist, you will play a critical role in ensuring the smooth operation of our office facilities.Key Responsibilities:Conference Room Coordination: Plan, coordinate, and set up...

  • Cardiovascular Imaging Specialist

    3 weeks ago

    Round Rock, United States HealthCare Support Full time

    Cath Lab Technologist OpportunityHealthCare Support is seeking a skilled Cath Lab Technologist for a 13-week contract in Texas.Benefits of Working with HealthCare Support: Immediate enrollment in health insurance Dental insurance Life insurance Employee Assistance Program (EAP) Access to open investment accounts Licensure and certification reimbursements...

  • Electrical Systems Specialist

    4 weeks ago

    Round Rock, Texas, United States Texas State Full time

    Job SummaryWe are seeking a skilled Electrical Systems Specialist to join our team at Texas State University. As a key member of our Facilities Operations department, you will be responsible for performing journey-level electrical work, including installation, maintenance, and repair of campus electrical systems and equipment.Key ResponsibilitiesPerform all...

  • Computer Support Specialist

    4 weeks ago

    Round Rock, Texas, United States ATR Arena Technical Resources Full time

    Job Title: Computer Support SpecialistJob Summary:We are seeking a highly skilled Computer Support Specialist to join our team at ATR Arena Technical Resources. The successful candidate will be responsible for providing technical support and assistance to users and organizations using computer software or equipment.Key Responsibilities:Assess and...

  • Senior Network Systems Specialist

    2 weeks ago

    Round Rock, Texas, United States Actalent Full time

    Job Title: Senior Network Systems SpecialistReporting to the Networking Manager, the primary responsibilities of this role are the implementation of production networking systems, collaborating across multiple groups to meet project milestones while maintaining the current production model, and developing technical expertise to continuously improve our...

  • Electrical Systems Specialist

    3 weeks ago

    Round Rock, Texas, United States Texas State Full time

    Job Summary:As an Electrical Systems Specialist at Texas State University, you will be responsible for performing journey-level electrical work, including installation, maintenance, and repair of campus electrical systems and equipment. This role requires a valid Texas Journeyman Electrician License and knowledge of the National Electrical Code and...

  • IT Help Desk Support Specialist

    4 weeks ago

    Round Rock, United States K2 Staffing Full time

    Job OverviewWe are seeking a highly skilled IT Help Desk Support Specialist to join our team at K2 Staffing. The ideal candidate will have a strong background in networking and systems administration, with excellent communication and problem-solving skills.Key ResponsibilitiesProvide technical support and assistance to clients via phone, email, and...

  • IT Support Specialist

    2 weeks ago

    Round Rock, Texas, United States HDR Full time

    About the Role:At HDR, we're committed to creating a welcoming environment where every employee is valued and respected. As an IT Support Specialist, you'll play a vital role in helping us achieve this goal by providing exceptional technical support to our staff.Key Responsibilities:Apply technology to address business needs and constraintsAssist staff to...