Quality Assurance Technician.

Terumo Cardiovascular Group; Ann Arbor (MI); On-site; USD 51,000 - 57,000; Full time

Job summary

Terumo Cardiovascular Group in Ann Arbor is seeking a Quality Assurance professional to inspect, test, and audit raw materials and finished products, releasing them per documented procedures.

The role emphasizes patient safety and product quality, handling DHRs/EDHRs, non-conformances, and deviations, with opportunities to train others and support production. On-site work with occasional travel may be required.

Qualifications

• Minimum two years of prior quality assurance or manufacturing experience.
• Basic computer software skills, e.g. Microsoft Office.
• High school diploma or equivalent.

Responsibilities

• Inspect, test, and audit raw materials and finished products per documented procedures.
• Release finished product in accordance with procedures.
• Review DHRs/EDHRs and update paperwork; separate into loads for release.
• Verify, test, and release finished product per procedure.
• Inspect and release raw materials per procedure.
• Process deviations and quality bulletins per procedure.
• Provide training assistance to production or quality management associates.

Skills

QA experience

Manufacturing

Education

High school diploma

Tools

Microsoft Office

Job description

Select how often (in days) to receive an alert:

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 inspecting, testing, and auditing of raw materials and finished product, as well as releasing finished product in accordance with documented procedures and processes.

• 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. Compile, verify, and review Device History Records (DHRs / EDHRs) to ensure records are complete and correct. Escalate issues to non-conformance report as necessary.
• 3. Perform pre-sterile and post-sterile inspection of products according to procedure.
• 4. Inspect and release raw materials, components, sub-assemblies, and finished devices according to procedure.
• 5. Review (DHRs/EDHRs) and update with associated paperwork, separate into loads for release purposes.
• 6. Verify, test, and release finished product per procedure.
• 7. Inspect and release raw materials according to procedure.

Job Responsibilities (continued)

• 8. Process and investigate non-conformances and reworks according to procedure. Process deviations and quality bulletins according to procedure.
• 9. Provide assistance with training to production or quality management Associates when needed.
• 10. Provide production with assistance when needed.
• 11. Perform additional responsibilities, as needed, which may include: Updates to customer complaint travelers, stability testing, raw material issues, Bioburden/LAL sample preparation, other quality reporting, and environmental monitoring.
• 12. Prioritize workload and flow through assigned areas to meet production and customer needs.
• 13. Investigate customer complaint/not complaint disposable products as required.
• 14. Initiate change orders as necessary.
• 15. Perform other duties as assigned.

Working Conditions/Physical Requirements

The position exists in office, production, and/or warehouse environments with minimal exposure to automated equipment. May require gowning procedures for controlled environment. May involve exposure to bovine and/or human blood, requiring the use of protective equipment. May at times involve exposure to chemicals requiring the use of personal protective equipment. May require the use of eye protection, hand protection and depending on noise level, may require hearing protection.

Visual acuity in compliance with site specific Visual Acuity Program. Majority of workday is spent either standing or sitting. On occasion, may stoop, bend, reach, pull, etc. Typically includes frequent lifting of up to 10 lbs. and occasional lifting up to 50 lbs. Requires travel up to 10%. This position is not eligible to work remotely. 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 minimum of two years of prior quality assurance or manufacturing experience preferred. Basic computer software skills, i.e. Microsoft Office.

The annualized base salary range for this role is $24.61 to $27.28. 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