Quality & Design Engineer Medical Devices

Quality & Design Engineer - Medical Devices Body Balance System Las Vegas, NV Job Details Full-time $62,400 - $72,800 a year Benefits Health insurance Dental insurance Paid time off Vision insurance Qualifications Record keeping Google Workspace Google Sheets Google Docs Google Drive Technical documentation ISO standards

FDA 21 CFR

Part 11 Quality management Bachelor's degree Quality control documentation Medical device design Technical writing Quality standards in production Manufacturing Manufacturing company experience

ISO 13485

Internal audits FDA regulations Full Job Description At Body Balance System, you will play a visible role in bringing compliant, well-documented medical devices from development into production. This position sits at the center of Design and Quality, helping ensure our documentation, controls, and release processes are clear, traceable, and ready for real-world use. If you enjoy technical drafting, structured problem-solving, and work that directly supports product quality and compliance, this is a role where you can make an immediate impact. What you'll do Draft, edit, and maintain controlled documentation across Quality and Design & Development, including but not limited to procedures, work instructions, design records, validation documents, production checklists, supplier records, NCRs, and CAPAs. Support design controls across the product lifecycle, including planning, inputs, outputs, reviews, verification, validation, transfer, and changes, while maintaining the DHF and traceability between requirements, test evidence, and risk controls. Draft and revise schematics, drawings, layouts, and related technical documentation, ensuring updates flow into controlled records and downstream production documentation. Maintain key device documentation, including the medical device file, DMR, and DHR, to support compliant design, manufacturing, and production traceability. Support risk management, verification and validation, and process validation activities through protocol and report drafting, evidence organization, and documentation of risk controls in design and production records. Lead or support NCR and CAPA activities, including investigations, root cause analysis, action tracking, and effectiveness verification through closure. Maintain supplier, training, and production records, and support final inspection and release activities, including documentation review, acceptance checks, and authorized sign-off for product release. Help keep records current, organized, and inspection-ready for internal audits and external assessments. Ensure compliance to FDA and ISO standards and regulations Other items as needed

Required Experience:

Bachelor's degree in engineering, engineering technology, quality, manufacturing, life sciences, or a related field, or equivalent experience in a regulated or quality-focused manufacturing environment. Hands-on experience in medical device manufacturing within an FDA-regulated and ISO-aligned environment. Strong understanding of controlled documentation, revision control, traceability, and quality records in a regulated environment. Ability to interpret and apply standards and regulations such as ISO 13485 and 21 CFR Part 820; familiarity with ISO 14971 and

IEC 62304

is a plus. Strong working proficiency with Google Workspace, especially Google Docs, Google Sheets, Drive, and Gmail, with the ability to use these tools effectively for drafting, collaboration, tracking, and document control. Preferred Experience with ERP or QMS tools for documentation, training, or production records.

Pay:

$62,400.00 - $72,800.00 per year

Benefits:

Dental insurance Health insurance Paid time off Vision insurance Application Question(s): What ISO standards or regulations do you have a deep understanding of that would help you excel in this role?

Experience:

Technical Writing:

2 years (Required)

Design and Development :

2 years (Preferred)

Quality Control :

2 years (Preferred)

Medical Device Manufacturing:

2 years (Preferred)

Work Location:

In person