Quality Assurance Inspector.

Terumo Cardiovascular Group; Ann Arbor (MI); On-site; USD 43,000 - 48,000; Full time

Job summary

Terumo Cardiovascular Group in Ann Arbor, MI, is seeking a quality assurance inspector to inspect, test, audit raw materials and finished products, and release materials per site procedures.

You will review eDHRs, perform pre-sterile and post-sterile inspections, document results, log non-conformances, assist in investigations, and support training within the Quality function. This is an on-site role requiring adherence to quality policies and procedures.

Qualifications

• Requires a high school diploma or equivalent and a minimum of one year of quality assurance or manufacturing experience.
• Basic computer software skills, i.e. Microsoft Office.

Responsibilities

• Inspect incoming materials by confirming specifications, conducting visual and measurement tests.
• Review eDHRs and release finished goods. Perform pre-sterile and post-sterile inspection of products according to procedure as appropriate.
• Documents inspection results by completing reports and logs; verbal/written communication of information to other departments as appropriate.
• Communicate, create, and log non-conformances and assist in investigations as appropriate.
• Maintain non-conforming material inventory, and daily laboratory environment conditions.
• Assist with any training needs within Quality or to other departments.
• Provide support in a quality function to other departments as needed.
• Perform other duties as assigned.

Skills

Quality Assurance

Microsoft Office

Education

High School Diploma

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 inspecting, testing, and auditing of raw materials, as well as finished product, and releasing materials as applicable by site.

Job 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.
• Inspects incoming materials by confirming specifications, conducting visual and measurement tests.
• Review eDHRs and release finished goods. Perform pre-sterile and post-sterile inspection of products according to procedure as appropriate.
• Documents inspection results by completing reports and logs; verbal/written communication of information to other departments as appropriate.
• Communicate, create, and log non-conformances and assist in investigations as appropriate.
• Maintain non-conforming material inventory, and daily laboratory environment conditions.
• Assist with any training needs within Quality or to other departments.
• Provide support in a quality function to other departments as needed.
• Perform other duties as assigned.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

The position exists in a manual production or warehouse environment with minimal exposure to automated equipment. May require gowning procedures for controlled environment. May at times involve exposure to chemicals that have fume removal by exhaust system 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 include frequent lifting of up to 10 lbs. and occasional lifting up to 50 lbs. This position is not eligible for remote work. 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.

Knowledge, Skills and Abilities (KSA)

Qualifications/ Background Experiences

Requires a high school diploma or equivalent and a minimum of one year of quality assurance or manufacturing experience. 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