Device History Record Reviewer.

Terumo Cardiovascular; Ann Arbor (MI); Hybrid; USD 29.000 - 32.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality assurance

Documentation

Microsoft Office

Ausbildung

High school diploma or equivalent

Two-year college degree preferred

Tools

Microsoft Office

Jobbeschreibung

At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products. Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.

At Terumo we’re working to build a healthier, happier society for our associates and the world. Our story begins over 100 years ago in Japan. Since then, we’ve been united by our mission to contribute to society through healthcare. As an associate at Terumo, your work helps to shape our evolution for the future. Working as one team, learning, innovating and challenging ourselves to write the future of healthcare. And no matter the location, no matter the team, we look out for one another, respect and support each other, strengthening trust with patients and healthcare providers everywhere.

Job Summary

This position is responsible for performing an independent quality review of in-process and final product device history records, with the primary goal of ensuring accurate documentation.

Job Details/Responsibilities

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.2. Ensure accuracy and completeness of device history records (DHRs).
• Obtain corrections on records 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.

Working Conditions/Physical Requirements

The position exists in a production environment within a manufacturing facility. May require the use of eye protection, hand protection, and, depending on noise level, may require hearing protection. Requires sitting for long periods of time with occasional stooping, bending, reaching, grasping, etc. May require occasional lifting, carrying, pushing, pulling, of objects up to, but not limited to, 10 lbs. Frequent repetitive motion tasks performed. This position may be eligible to work remotely 10% of the time. This may change based on job responsibilities, project/business needs and/or Associate job performance. In all cases Associates may need to have on-site presence for designated meetings and compliance related activities.

Qualifications/ Background Experiences

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, i.e. Microsoft Office.

The annualized base wage range for this role is $20.86 to $23.12 per hour. Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

At Terumo, we genuinely care about our Associates. That’s why we offer a wide range of benefits designed to support your health, happiness, and future. Take a closer look at what we provide.

• 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