Device History Record Reviewer.

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

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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.

1. 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).
3. Obtain corrections on records from applicable personnel.
4. Record number and types of errors found on records.
5. Identify nonconforming records and initiate nonconformance reports (NCRs), as applicable.
6. Recommend changes to records for improved usability.
7. 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 salary range for this role is $20.86 to $23.12. Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.

EOE Minorities/Women/Disabled/Veterans

Nearest Major Market: Ann Arbor
Nearest Secondary Market: Detroit