Terumo Cardiovascular Group
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Department: Quality Engineering Operations
Terumo Medical Corporation (TMC) develops, manufactures, and markets a comprehensive portfolio of high-quality medical devices used across various healthcare applications. TMC emphasizes providing customers with world-class products, training, and education programs that deliver economic value, improved clinical outcomes, and enhanced quality of life for patients. As part of Tokyo-based Terumo Corporation, a leading global medical device manufacturer with over $6 billion in sales, 30,000+ employees, and operations in more than 160 countries, TMC is divided into two strategic business units: Terumo Interventional Systems and Terumo Medical Products.
We believe in a bright future for everyone at Terumo, fostering lasting change, creating greater impact, and achieving superior outcomes now and in the future.
At Terumo, we value personal growth and encourage you to take charge of your development—deepening your skills and progressing in your career. We promote bold thinking, innovation, and delivering the next breakthroughs in healthcare. Join our collaborative, respectful, and resilient global team of associates and leaders working together to provide impactful solutions for patients.
Join us and help shape the future!
Advancing healthcare with heart
This role involves investigating, planning, and implementing improvements or additions to current products and manufacturing processes to enhance safety, quality, and productivity, ultimately producing better products more efficiently. Responsibilities include ensuring compliance with Terumo's quality policies, responding to customer complaints, conducting audits, developing test methods, and writing procedures for material characterization.
The key responsibilities include:
Proactively investigating and implementing best-in-class Quality Engineering practices.
Providing focused quality engineering support and managing project activities.
Establishing effective corrective action plans and leading quality assurance initiatives.
Supporting quality disciplines and decision-making as a team member or leader.
Applying systematic problem-solving methodologies to quality issues.
Reviewing and approving qualification, validation, and change control documentation.
Developing product and process assurance plans and implementing process control systems.
Generating quality documentation such as plans, SOPs, and inspection procedures.
Participating in Product Review Boards and analyzing customer/internal complaints.
Conducting analytical measurements and experiments for product/process qualification.
Developing and implementing strategic quality and validation plans to meet FDA and ISO requirements.
Tracking quality trends and managing corrective actions.
Monitoring field quality and analyzing returns to determine root causes.
Providing training and support on quality systems and practices.
Internal contacts include all departments such as manufacturing, engineering, and sales, while external contacts involve customers and vendors.
Benefits / Compensation
We offer competitive benefits including paid vacation, holidays, health/dental/vision insurance, 401(k) with matching, savings accounts, legal plans, voluntary insurance options, parental and personal leave, tuition reimbursement, travel assistance, and employee assistance programs. The pay range is $86,600 - $129,800. Knowledge, Skills, and Abilities (KSA)
Excellent verbal and written communication skills. Strong organizational and time management skills for project work. Preferred certifications: CQA, CQE, or CQM, and membership in ASQ. Strong skills in writing, mathematics, and statistics. Qualifications/Background Experiences
Minimum of a 4-year degree in engineering, life sciences, or related field. Six to ten years of increasing responsibility in a medical device quality assurance environment. Preferred: one to two years of auditor experience. Terumo is committed to equal employment opportunity, valuing diversity and prohibiting discrimination or harassment based on any protected class. We offer a comprehensive benefits package tailored to individual needs.
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We offer competitive benefits including paid vacation, holidays, health/dental/vision insurance, 401(k) with matching, savings accounts, legal plans, voluntary insurance options, parental and personal leave, tuition reimbursement, travel assistance, and employee assistance programs. The pay range is $86,600 - $129,800. Knowledge, Skills, and Abilities (KSA)
Excellent verbal and written communication skills. Strong organizational and time management skills for project work. Preferred certifications: CQA, CQE, or CQM, and membership in ASQ. Strong skills in writing, mathematics, and statistics. Qualifications/Background Experiences
Minimum of a 4-year degree in engineering, life sciences, or related field. Six to ten years of increasing responsibility in a medical device quality assurance environment. Preferred: one to two years of auditor experience. Terumo is committed to equal employment opportunity, valuing diversity and prohibiting discrimination or harassment based on any protected class. We offer a comprehensive benefits package tailored to individual needs.
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