Quality Inspector (Medical Devices)

Location: Skaneateles, New York, United States; onsite, 2nd shift

Salary: $44,800–$61,600 annually

Company

hirify.global develops and manufactures healthcare products intended to support patient care and save and sustain lives.

What you will do

• Inspect device and module documentation, testing records, labels, visual features, and finished products before release.
• Review device event histories and verify that required testing values and results are accurately recorded.
• Approve device, module, and spare-parts-kit releases in the applicable ERP systems.
• Record failed observations, manage nonconformances, and disposition rework through approved electronic systems.
• Identify out-of-compliance conditions and help contain nonconforming products for investigations and holds.
• Verify compliance with process controls, maintenance procedures, FDA requirements, and manufacturing work rules.

Requirements

• High school diploma and 2–4 years of related experience.
• Experience in pharmaceutical or biotech manufacturing is helpful.
• Must be familiar with cGMP and FDA requirements and GMP documentation.
• Knowledge of measurement equipment, basic ESD requirements, computer programs, data entry, and spreadsheets.
• Ability to perform visual inspections, identify particulate or foreign matter, and distinguish colors as required by FDA cGMP.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Culture & Benefits

• Work in a temperature- and humidity-controlled manufacturing environment with FDA-regulated procedures.
• Wear required static-protective clothing and grounding equipment in the production area.
• May need to work flexible hours and overtime on short notice.
• Benefits include medical and dental coverage from day one, disability and life insurance, 401(k) matching, ESPP, paid time off, paid holidays, parental leave, and educational assistance.
• Physical requirements include prolonged sitting, standing or walking, repetitive hand movements, hand-eye coordination, and lifting or carrying up to 23 pounds.