Quality Inspector (Medical Devices)

Location: Skaneateles, NY, United States; onsite manufacturing environment

Company

Develops and manufactures healthcare products and medical devices with a mission to save and sustain lives.

What you will do

• Inspect device and module documentation, testing records, visual features, labels, and serial numbers before final release.
• Approve device, module, and spare parts kit releases in the appropriate ERP systems.
• Check for open nonconformances, review event history logs, and record failing observations.
• Disposition rework activities and complete electronic approval and closure of nonconformances.
• Identify out-of-compliance conditions and help contain nonconforming products for investigations and holds.
• Verify that process control and maintenance procedures are followed in the manufacturing environment.

Requirements

• High school diploma or GED.
• Working knowledge of measurement equipment, cGMP documentation, FDA requirements, and basic ESD requirements.
• Experience with computer programs, data entry, and spreadsheet applications.
• Strong attention to detail, accuracy, and communication skills.
• Ability to visually identify particulate or foreign matter and distinguish colors as required by FDA current Good Manufacturing Practices.
• Ability to sit for most of the workday, stand or walk for extended periods, lift and carry up to 23 pounds, and work flexible hours or overtime on short notice.

Nice to have

• Experience in the pharmaceutical or biotech industry.

Culture & Benefits

• Full-time employment in a regulated manufacturing environment.
• Medical and dental coverage beginning on day one for eligible roles.
• Life, accident, short- and long-term disability, and business travel accident insurance.
• 401(k) retirement savings plan, employee stock purchase plan, flexible spending accounts, and educational assistance.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.