Sr Quality Engineer

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

 

 

 

 

Job Summary

This position is responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently. Ensure compliance to Terumo’s quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization. 

 

Job Details/Responsibilities

1.    Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. 
2.    Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.  
3.    Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
4.    Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
5.    Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
6.    Review and approve product and process qualification and validation and other change control related documentation.
7.    Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
8.    Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. 
9.    Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
10.    Performs analytical measurements and experiments to qualify or resolve product and process issues.
11.    Will be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements. 
12.    Track quality trends and initiate action items to resolve issues.  Manage assigned corrective actions.  
13.    Monitor field quality and analyze field returns to determine root cause. 
14.    Provide training and support for quality system processes and quality engineering practices.  

Internal contacts:  All departments, including manufacturing, engineering, marketing/sales.

External contacts: Customers and vendor contacts regarding purchases and services.  
 

Benefits / Compensation

We provide competitive and comprehensive benefit options that allow you to design your own