Device History Records QA Specialist

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

Benefits offered by this job

401(k) with 6% matching

Paid time off

Company paid holidays

Medical, dental, vision insurance

Flexible spending account

Health savings account

Company paid life insurance

Employee assistance program

Parental leave

Tuition reimbursement

Onsite Gym

Job summary

Terumo Cardiovascular is seeking a QA-focused professional to perform independent quality reviews of in-process and final product device history records. You will ensure accuracy and completeness of DHRs, document errors, and initiate NCRs when applicable, contributing to patient safety and product quality.

In this role, you will record error types, propose improvements to records, and carry out additional duties as needed in a production environment, with occasional remote work up to 10% of

Qualifications

• Requires a high school diploma or equivalent.
• A two-year college degree is preferred.
• Prior quality assurance or manufacturing experience in a regulated industry is preferred.
• Basic computer software skills, e.g. Microsoft Office.

Responsibilities

• Perform an independent quality review of in-process and final product device history records.
• Ensure accuracy and completeness of device history records (DHRs).
• Record number and types of errors found on records; identify nonconforming records and initiate NCRs.
• Recommend changes to records for improved usability; perform other duties as assigned.

Skills

Quality assurance

Documentation

Microsoft Office

Education

High school diploma or equivalent

Two-year college degree preferred

Tools

Microsoft Office

Job description

Terumo Cardiovascular is seeking a QA-focused professional to perform independent quality reviews of in-process and final product device history records. You will ensure accuracy and completeness of DHRs, document errors, and initiate NCRs when applicable, contributing to patient safety and product quality.

In this role, you will record error types, propose improvements to records, and carry out additional duties as needed in a production environment, with occasional remote work up to 10% of