Medical Device QA & Evaluation Operator I

KARL STORZ North America; Auburn (MA); On-site; USD 42,000 - 58,000; Full time

Job summary

KARL STORZ North America is seeking a Product Evaluation Operator I to ensure medical devices, instruments, and software meet quality and safety standards before returning to inventory or shipping. You will perform hands-on evaluations, document results, and help determine disposition.

The role requires attention to detail, ability to follow procedures, and the capacity to work in a regulated MedTech environment with SAP-based transactions and cross-functional collaboration.

Qualifications

• High School Diploma or GED required.
• Minimum 1 year of experience with SAP/ERP/WMS or similar systems.
• Working knowledge of Microsoft Office applications.
• Ability to follow detailed procedures and controlled processes.
• Strong communication, organizational and problem-solving skills.
• Ability to work independently while contributing to a team.

Responsibilities

• Perform hands-on evaluations of medical devices, instruments, and software to assess functionality against standards.
• Execute SAP and related system transactions to document evaluations and disposition outcomes.
• Support the Global KSRAPS-FCO process for compliant product disposition decisions.
• Maintain inventory accuracy and documentation integrity; ensure quality and regulatory compliance.
• Participate in LEAN, 6S, audits, visual management and continuous improvement initiatives.
• Assist with work instruction updates and cross-training within the department.

Skills

SAP/ERP/WMS experience

Microsoft Office

Attention to detail

Communication skills

Independent with teamwork

Education

High School Diploma or GED

Tools

SAP

ERP systems

WMS

Job description

KARL STORZ North America is seeking a Product Evaluation Operator I to ensure medical devices, instruments, and software meet quality and safety standards before returning to inventory or shipping. You will perform hands-on evaluations, document results, and help determine disposition.

The role requires attention to detail, ability to follow procedures, and the capacity to work in a regulated MedTech environment with SAP-based transactions and cross-functional collaboration.