Quality Assurance Specialist (ISO 13485)

Job Description

Our clients choose Supera because we can prove what we did, when we did it, and with which materials. The Quality Assurance Specialist is the person who makes that provable. You’ll maintain and improve the quality management system that underpins our FDA device establishment registration and ISO 13485 certification.

Day to day, you’ll review batch records and device history files for completeness, perform and document in-process and final inspections, manage nonconformance reports, and drive corrective and preventive actions through to verified closure. You’ll also maintain controlled documents – work instructions, SOPs, and forms – so the floor is always building to the current approved revision.

You’ll be a primary point of contact during client audits, notified body assessments, and FDA inspections, and you’ll partner with operations to investigate deviations without turning every finding into a bottleneck. The best people in this role are firm on the standard and practical about how work actually gets done.

Job Requirements

We’re looking for someone who understands that quality is a system, not a checkpoint. You should be fluent in the language of regulated manufacturing and comfortable holding a line when production pressure is high. Strong writing skills matter here – much of the job is producing records that will be read years from now by someone who wasn’t in the room.

Required qualifications:

  • Bachelor’s degree in a life science, engineering, or related field – or equivalent relevant experience
  • 2+ years in a quality role within a medical device, diagnostics, or pharmaceutical environment
  • Working knowledge of ISO 13485 and FDA 21 CFR Part 820
  • Hands-on experience with nonconformance, CAPA, and document control processes
  • Excellent technical writing and record-keeping skills
  • Ability to read, interpret, and apply regulatory standards to day-to-day operations

Preferred qualifications:

  • Experience supporting FDA inspections or notified body audits
  • Internal auditor certification (ISO 13485 or ISO 9001)
  • Familiarity with cleanroom environmental monitoring programs
  • Experience with electronic QMS platforms
  • Working knowledge of risk management principles (ISO 14971)
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