Sr Quality Engineer 1

Department : Quality Engineering Operations

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.

This position is responsible for investigating, planning, and implementing improvements in and / or additions to current products and manufacturing processes that directly affect 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.

Responsibilities

• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Provide focused quality engineering support and assume responsibility for timely and effective coordination and / or execution of assigned development project activities.
• 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.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Review and approve product and process qualification and validation and other change control related documentation.
• Develop product / process assurance plans, which include all required elements.
• Generate internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
• Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans.
• Perform analytical measurements and experiments to qualify or resolve product and process issues.
• Develop and implement strategic quality plans, master validation plans, validation protocols, inspection plans, and quality / regulatory compliance operating procedures to meet FDA and ISO requirements.
• Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.
• Monitor field quality and analyze field returns to determine root cause.
• Provide training and support for quality system processes and quality engineering practices.

Qualifications / Background Experiences

Knowledge, Skills and Abilities (KSA)

Benefits / Compensation

We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include : paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range is $86,600 - $129,800.

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information, or any other category protected by law.

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