Quality Inspector (Medtech)

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

Salary: $44,800–$61,600 annually

Company

Medical technology company developing and manufacturing products intended to improve healthcare delivery and sustain lives.

What you will do

• Inspect device and module history records, test procedures, release specifications, event logs, and visual product characteristics.
• Verify customer-facing labels, packaging labels, serial numbers, and approved device markings.
• Approve device, module, and spare-parts-kit releases in the applicable ERP system.
• Record inspection failures, add quality flags, and manage nonconformance documentation in SAP and other electronic systems.
• Disposition rework, complete electronic approval and closure processes, and support containment of nonconforming products.
• Monitor process controls and maintenance procedures, identify out-of-compliance or out-of-tolerance conditions, and take appropriate action.

Requirements

• High school diploma and 2–4 years of related experience.
• Must be authorized to work for any employer in the United States; visa sponsorship and sponsorship transfer are not available.
• Knowledge of cGMP, FDA requirements, and GMP documentation.
• Ability to visually inspect products for particulate or foreign matter and distinguish colors as required by FDA cGMP.
• Working knowledge of measurement equipment, basic ESD requirements, computer programs, data entry, and spreadsheets.
• Strong attention to detail and accuracy, communication skills, hand-eye coordination, and ability to lift and carry up to 23 pounds.

Nice to have

• Experience in the pharmaceutical or biotech industry.
• Knowledge of aseptic techniques.

Culture & Benefits

• FDA-regulated, temperature- and humidity-controlled manufacturing environment.
• Required use of static-protective clothing and grounding equipment at ESD-sensitive stations.
• Medical and dental coverage begins on day one for eligible roles.
• Benefits include life, disability, and travel accident insurance, 401(k) matching, ESPP, flexible spending accounts, educational assistance, paid time off, and parental leave.
• Flexible hours and short-notice overtime may be required.