Quality control analyst Jobs in Ann Arbor, MI

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 working between Terumo and our suppliers, providing guidance on product and component quality requirements. The supplier quality engineer is responsible for all activities related to supplier evaluation, qualifying components at the suppliers site, and supplier performance.

Job Details/Responsibilities

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. Communicating to the potential supplier the selection requirements so that the supplier evaluation process is understood by the supplier.
3. Participating in audits at suppliers sites, covering quality system and production line capability so that a recommendation can be made on their ability to produce and deliver product. Completing audit reports along with recommendations. Issuing corrective actions requests stemming from findings related to the quality system audit. Working with the supplier to determine root cause and implement actions to address findings. This can also include process or audits of suppliers production lines and/or quality system to ensure conformity to Terumo requirements.
4. Gathering and reviewing all documents required for the supplier selection process.
5. Participating as a cross-functional team member within Terumo's design control process to launch new product and/or changes to current product for part qualification at the supplier's site.
6. Conducting design transfer review meetings with the supplier to ensure Terumo's design requirements are manufacturable and clearly communicated.
7. Responsible for implementing controls at the supplier to ensure shipped product meets design specifications. Controls may include execution of process and test method validations, Gage R&R, SPC, DOE , PFMEA, Control Plans, and Work Instructions. Also, outlining and communicating first article inspection requirements to the supplier. Upon receipt of first article inspection data, reviewing the data for adequacy and approving.
8. Working within Terumo's SNCR and SCAR process when nonconformances are identified. This includes working with the supplier to ensure containment of impacted product, correction of product, and implementation of corrective and preventive actions to prevent future occurrences. Quality incident resolution may require site visits to a supplier's facility to better understand the issue.
9. Monitoring supplier performance to ensure effectiveness of supplier SCAR responses.
10. Preparing quarterly quality data for supplier's scorecard evaluation and communication of performance to the supplier and applicable Terumo team members.
11. Executing, jointly with the supplier, continuous improvement plans when supplier performance has become an issue.
12. Providing feedback to Terumo team members on status of identified nonconformances and related activities. Meeting with Terumo management to assist with escalations and problem resolution.
13. Perform other duties as assigned.

Qualifications/ Background Experiences

Requires a four-year college degree in an engineering, scientific, or technical discipline. Must have proficient computer software skills, i.e. Microsoft Office - Word, Excel and Outlook.

The annualized base salary range for this role is $59,850.00 to $75,167.00. 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