Device History Records QA Specialist (Remote)

Terumo Cardiovascular Group; Ann Arbor (MI); Hybrid; USD 29,000 - 32,000; Full time

Job summary

Terumo Cardiovascular Group is seeking a Quality Review professional to independently review device history records (DHRs) across in-process and final products, ensuring precise documentation and adherence to quality standards. You will identify errors, initiate NCRs when needed, and recommend improvements while maintaining patient safety as a top priority.

The role supports manufacturing in Michigan, with a remote work option up to 10% of the time and opportunities for collaboration across

Qualifications

• High school diploma or equivalent required.
• Two-year college degree preferred.
• Prior quality assurance or manufacturing experience in a regulated industry preferred.
• Basic computer software skills, i.e. Microsoft Office.

Responsibilities

• Perform independent quality review of in-process and final product device history records (DHRs) to ensure accurate documentation.
• Demonstrate commitment to patient safety and product quality by complying with Quality Policy and procedures.
• Ensure accuracy and completeness of device history records and obtain corrections from applicable personnel.
• Record number and types of errors found on records.
• Identify nonconforming records and initiate nonconformance reports (NCRs) as applicable.
• Recommend changes to records for improved usability.
• Perform other duties as assigned.

Skills

Basic computer skills

Microsoft Office

Education

High school diploma or equivalent

Two-year college degree preferred

Tools

Microsoft Office

Job description

Terumo Cardiovascular Group is seeking a Quality Review professional to independently review device history records (DHRs) across in-process and final products, ensuring precise documentation and adherence to quality standards. You will identify errors, initiate NCRs when needed, and recommend improvements while maintaining patient safety as a top priority.

The role supports manufacturing in Michigan, with a remote work option up to 10% of the time and opportunities for collaboration across