Quality Assurance Technician.

Terumo • Ann Arbor, MI

7d • $25 - $27 • Onsite

About The Position

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.

Requirements

• Requires a high school diploma or equivalent.
• Basic computer software skills, i.e. Microsoft Office.

Nice To Haves

• A minimum of two years of prior quality assurance or manufacturing experience preferred.

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.
• Compile, verify, and review Device History Records (DHRs / EDHRs) to ensure records are complete and correct. Escalate issues to non-conformance report as necessary.
• Perform pre-sterile and post-sterile inspection of products according to procedure.
• Inspect and release raw materials, components, sub-assemblies, and finished devices according to procedure.
• Review (DHRs/EDHRs) and update with associated paperwork, separate into loads for release purposes.
• Verify, test, and release finished product per procedure.
• Inspect and release raw materials according to procedure.
• Process and investigate non-conformances and reworks according to procedure. Process deviations and quality bulletins according to procedure.
• Provide assistance with training to production or quality management Associates when needed.
• Provide production with assistance when needed.
• 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.
• Prioritize workload and flow through assigned areas to meet production and customer needs.
• Investigate customer complaint/not complaint disposable products as required.
• Initiate change orders as necessary.
• Perform other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED