Medical Device Quality Assurance Technician (ISO 13485/MDSAP)

Job Description

Job DescriptionStep into a day where quality protects patients

You grab your notebook and log into our global quality system. A production line pause pops up—within minutes, you’re on the floor confirming evidence, scoping the issue, and launching a documented investigation. By midday you’re coordinating in-process sub-assembly checks and final product acceptance tests; by afternoon you’re verifying calculations and dose ranges, confirming dosimeter placement and special instructions prior to processing, and clearing a batch for release after a thorough Device History Record (DHR) review. Before you wrap, you complete a calibration task, record environmental monitoring results, and close out your Material Review Board (MRB) notes.

What you will do

• Support manufacturing and servicing operations by performing and documenting problem-solving investigations, including production line stoppages and associated corrective actions.
• Coordinate and conduct in-process and final QC product acceptance testing for sub-assemblies and finished devices.
• Identify and document product and process nonconformances; participate in MRB activities to disposition nonconformance reports.
• Review DHRs and support batch record and product/process release decisions.
• Enter and retrieve quality data in local and global systems to maintain complete, accurate records.
• Perform site calibration activities and maintain traceable records.
• Execute environmental monitoring and associated documentation.
• Verify calculations, dose ranges, dosimeter placements, and any special instructions prior to processing and as part of final product release.
• Carry out other quality-related duties as assigned.

The standards you’ll champion

Our products and processes align to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory requirements. You will help ensure day-to-day adherence in everything we build, test, document, and release.

What you bring

Required (one of the following):

• High school diploma or GED plus at least 3 years of experience in a manufacturing or repair setting or in technical production tasks; or
• Associate’s degree plus at least 1 year of experience in a manufacturing or repair setting or in technical production tasks.

Preferred:

• Hands-on experience working with electrical wiring in a testing capacity.
• Proficiency with measuring tools.
• Demonstrated skill in visual inspection and hands-on product evaluation.

If you thrive on meticulous documentation, structured problem-solving, and seeing safe, compliant product move to patients, this role will feel like home.